ABBV AbbVie Inc.

107.54
+1.44  (+1%)
Previous Close 106.1
Open 106.39
52 Week Low 78.56
52 Week High 113.41
Market Cap $189,789,367,070
Shares 1,764,825,805
Float 1,763,303,083
Enterprise Value $264,825,017,910
Volume 5,977,405
Av. Daily Volume 7,441,293
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Upcoming Catalysts

Drug Stage Catalyst Date
RINVOQ (upadacitinib)
Active Ankylosing Spondylitis
PDUFA
PDUFA
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Upadacitinib
Psoriatic arthritis
PDUFA
PDUFA
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Upadacitinib
Atopic Dermatitis
PDUFA
PDUFA
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Atogepant
Chronic migraine
PDUFA
PDUFA
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Cenicriviroc (CVC)
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
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ABBV-951
Parkinson's disease
Phase 3
Phase 3
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Imbruvica + Venclexta (GLOW)
Chronic Lymphocytic Leukemia
Phase 3
Phase 3
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Imbruvica (SHINE)
Mantle Cell Lymphoma
Phase 3
Phase 3
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Upadacitinib
Crohn's disease (induction/maintenance)
Phase 3
Phase 3
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Upadacitinib
Ulcerative Colitis (induction/maintenance)
Phase 3
Phase 3
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Venetoclax - CANOVA
Relapsed or refractory multiple myeloma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Risankizumab MOTIVATE
Crohn’s Disease
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 7, 2021.
AGN-190584
Presbyopia
NDA Filing
NDA Filing
NDA filing announced February 25, 2021.
Botox
Neurogenic Detrusor Overactivity
Approved
Approved
FDA approval announced February 10, 2021.
Cariprazine (Vraylar)
Major depressive disorder
Phase 3
Phase 3
Phase 3 data due 2021.
Risankizumab KEEPSAKE2
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 5, 2021.
Imbruvica + Venclexta (CAPTIVATE)
Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Phase 2
Phase 2
Phase 2 trial ongoing.
Ibrutinib in combination with prednisone
Chronic Graft Versus Host Disease
Phase 3
Phase 3
Phase 3 trial ongoing.
Upadacitinib - U-ACHIEVE
Ulcerative colitis
Phase 3
Phase 3
Phase 3 trial met primary and secondary endpoints - December 9, 2020.
Depatuxizumab mafodotin ABT-414
Glioblastoma (rGBM)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint at interim analysis - May 17, 2019.
Venclexta (VIALE-A)
Acute Myeloid Leukemia (AML)
Approved
Approved
FDA approval announced October 16, 2020.
ABT-494
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 trial to commenced 2017.
Ibrutinib
COVID-19
Phase 2
Phase 2
Phase 2 trial has been initiated.
Risankizumab vs secukinumab
Plaque psoriasis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 14, 2020.
Upadacitinib
Atopic dermatitis
Phase 3
Phase 3
Phase 3 data met co-primary endpoints - June 18, 2020. Second Phase 3 trial also met primary endpoint - July 21, 2020.
ABICIPAR
Age-related macular degeneration (AMD)
CRL
CRL
CRL issued June 26, 2020.
Botox
Forehead lines
Approved
Approved
Approval (third indication) announced October 3, 2017.
JUVÉDERM VOLUMA
Augmentation of the chin region
Approved
Approved
FDA Approval announced June 15, 2020.
Elagolix
Uterine Fibroids
Approved
Approved
FDA approval announced May 29, 2020.
Oxymetazoline HCl cream 1.0%
Facial Erythema (Redness) Associated with Rosacea
Approved
Approved
Approved January 19, 2017.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved
Approved September 14, 2017.
Botox
Lower limb spasticity
Approved
Approved
FDA Approval announced October 24, 2019.
Ubrogepant
Migraine
Approved
Approved
FDA Approval announced December 23, 2019.
Botox
Upper limb spasticity
Approved
Approved
FDA Approval announced June 21, 2019.
Juvéderm VOLUMA
Mid-Face Injection Via Cannula
Approved
Approved
FDA Approval announced September 3, 2019.
IMBRUVICA (ibrutinib) and rituximab
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Approved
Approved
FDA Approval announced April 21, 2020.
Rova-T (MERU)
First-line Small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial demonstrated no survival benefit at interim analysis - October 29, 2019.
Risankizumab ( LIMMITLESS )
Psoriasis
Phase 3
Phase 3
Phase 3 data presented at EADV October 10, 2019.
Veliparib
Ovarian cancer
Phase 3
Phase 3
Phase 3 presentation at ESMO 28 September 2019.
ABT-494 upadacitinib
Rheumatoid arthritis
Approved
Approved
FDA Approval announced August 16, 2019.
ABBV-8E12
Alzheimer's disease
Phase 2
Phase 2
Phase 2 initiation announced January 25, 2017.
Rova-T (TAHOE)
Second-line Small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 enrolment to be stopped due to shorted overall survival following recommendation from Independent Data Monitoring Committee (IDMC) December 5, 2018.
Venetoclax and obinutuzumab
Chronic lymphocytic leukemia
sNDA Filing
sNDA Filing
sNDA filing announced June 4, 2019.
Venetoclax and obinutuzumab
Chronic Lymphocytic Leukemia
Phase 3
Phase 3
FDA approval announced May 15, 2019.
Risankizumab
Psoriasis
Approved
Approved
FDA approval announced April 23, 2019.
Venclexta BELLINI
Multiple myeloma
Phase 3
Phase 3
Phase 3 primary endpoint met.
Imbruvica and Gazyva - iLLUMINATE
Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
Approved
Approved
FDA approval announced January 28, 2019.
Ibrutinib (Imbruvica)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 primary endpoint not met (PFS/OS).
Venclexta
First line unfit AML
Approved
Approved
FDA approval announced November 21, 2018.
IMBRUVICA (ibrutinib)
Waldenström’s Macroglobulinemia
Approved
Approved
FDA approval announced August 27, 2018.
Elagolix
Endometriosis
Approved
Approved
FDA approval announced July 24, 2018.
IMBRUVICA (ibrutinib)
Diffuse large B-cell lymphoma (DLBCL)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 11, 2018.
Venclexta (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Approved
Approved
Approval announced June 11, 2018.
Rova-T (TRINITY)
Third-line Small Cell Lung Cancer
Phase 2
Phase 2
Phase 2 pivotal data released March 22, 2018. ORR of 16% + overall survival 5.6 months noted. Abstract 8507.
Imbruvica
Second-line Chronic graft-versus-host disease (GVHD)
Approved
Approved
Approval announced August 2, 2017.
Imbruvica
Marginal zone lymphoma
Approved
Approved
sNDA filing announced September 26, 2017. Priority Review. Approved January 19, 2017.
Glecaprevir/Pibrentasvir (G/P)
Hepatitis C virus (HCV)
Approved
Approved
Approval announced August 3, 2017.
IMBRUVICA
Waldenström’s Macroglobulinemia
Approved
Approved
Approved January 29, 2015 - PCYC
VIEKIRA PAK
HCV - genotype 1
Approved
Approved
Approved December 19, 2014.
Imbruvica
Deletion 17p
Approved
Approved
Approved July 19, 2014.
Imbruvica
Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Approved
Approved
Approved February 12, 2014.
Ibrutinib
Relapsed or refractory MCL mantle cell lymphoma
Approved
Approved
Approved November 13, 2013.
Veliparib
Squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoints - April 19, 2017.

Latest News

  1. NORTH CHICAGO, Ill., April 7, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted applications seeking approval for SKYRIZI® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis.1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).1

    "Most patients living with psoriatic arthritis experience both skin and…

    NORTH CHICAGO, Ill., April 7, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted applications seeking approval for SKYRIZI® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis.1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).1

    "Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome. Despite advancements, many patients cannot find relief from the signs and symptoms of this disease," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals."

    In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, SKYRIZI demonstrated significant improvements in disease activity (as measured by ACR20 response and minimal disease activity), skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]) and physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) at week 24 versus placebo.1* In both studies, significantly more patients treated with SKYRIZI achieved the primary endpoint of ACR20 response at week 24 versus placebo.1 The safety profile of SKYRIZI in these studies was generally consistent with the safety profile of SKYRIZI in plaque psoriasis, with no new safety risks observed.1,6-8

    SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

    *Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient's Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1. Skin symptoms were measured by a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90). Physical function was measured by the HAQ-DI.

    About Psoriatic Arthritis

    Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.3,4 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.3,4

    About KEEPsAKE-1 and KEEPsAKE-21,9,10

    KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to SKYRIZI 150 mg or placebo followed by SKYRIZI 150 mg at week 24. Patients randomized to SKYRIZI received four maintenance doses a year, following two initiation doses.

    The primary endpoint for both studies was the achievement of ACR20 response at week 24. Ranked secondary endpoints included change from baseline in HAQ-DI, as well as the achievement of PASI 90 and minimal disease activity (MDA) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of SKYRIZI in patients who have completed the placebo-controlled period.

    More information on these trials can be found at www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).

    About SKYRIZI® (risankizumab)

    SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.11,12 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.9,10,13-15 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

    About SKYRIZI® (risankizumab-rzaa) in the United States12

    SKYRIZI is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

    Important Safety Information12

    What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)?

    SKYRIZI may cause serious side effects, including infections. SKYRIZI is a prescription medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

    • Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
      • fever, sweats, or chills
      • muscle aches
      • weight loss
      • cough
      • warm, red, or painful skin or sores on your body different from your psoriasis
      • diarrhea or stomach pain
      • shortness of breath
      • blood in your mucus (phlegm)
      • burning when you urinate or urinating more often than normal

    Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, 

    including if you:

    • have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"
    • have an infection that does not go away or that keeps coming back.
    • have TB or have been in close contact with someone with TB.
    • have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with SKYRIZI.
    • are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
    • are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    What are the possible side effects of SKYRIZI?

    SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

    The most common side effects of SKYRIZI include upper respiratory infections, fungal skin infections, headache, feeling tired, and injection site reactions.

    These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about

    side effects.

    Use SKYRIZI exactly as your healthcare provider tells you to use it.

    This is not a complete summary of all safety information.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.



    If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

    Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.

    Globally, prescribing information varies; refer to the individual country product label for complete information.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    References:

    1. AbbVie. Data on File: ABVRRTI71470. 
    2. Galezowski, A., et al. Rhumatisme psoriasique en France, du nourrisson à la personne âgée : données de deux études transversales multicentriques [Psoriatic arthritis in France, from infants to the elderly: Findings from two cross-sectional, multicenter studies]. Ann Dermatol Venereol. 2018;145(1):13-20. doi:10.1016/j.annder.2017.10.008.
    3. Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
    4. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on April 1, 2021.
    5. Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on April 1, 2021.
    6. Gordon K., et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
    7. Reich, K., et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3.
    8. Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded Results from the Phase 3 IMMhance Trial. Poster #478. 24th World Congress of Dermatology. 2019.
    9. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03675308. Accessed on April 1, 2021.
    10. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on April 1, 2021.
    11. Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
    12. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
    13. A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on April 1, 2021. 
    14. A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed on April 1, 2021.
    15. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03398148. April 1, 2021.

     

    Cision View original content:http://www.prnewswire.com/news-releases/abbvie-submits-regulatory-applications-for-skyrizi-risankizumab-in-psoriatic-arthritis-to-fda-and-ema-301264138.html

    SOURCE AbbVie

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  2. NORTH CHICAGO, Ill., April 7, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. A total of 33 abstracts, including one podium presentation during the Clinical Trials Plenary Session and three oral presentations, will be shared from a broad range of studies across the spectrum of migraine, advanced Parkinson's disease and spasticity.

    "Our strong presence at AAN reflects our expanded portfolio of approved and investigational treatments designed to address a wide range of complicated, often debilitating neurological disorders," said Michael Gold, M.D., vice president…

    NORTH CHICAGO, Ill., April 7, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. A total of 33 abstracts, including one podium presentation during the Clinical Trials Plenary Session and three oral presentations, will be shared from a broad range of studies across the spectrum of migraine, advanced Parkinson's disease and spasticity.

    "Our strong presence at AAN reflects our expanded portfolio of approved and investigational treatments designed to address a wide range of complicated, often debilitating neurological disorders," said Michael Gold, M.D., vice president, neuroscience development, AbbVie. "We look forward to sharing our progress in a number of areas, including pivotal Phase 3 data in migraine, with the goal of making a remarkable impact on patients' lives."

    Researchers will present data from several studies on migraine, including new findings on atogepant, AbbVie's investigational preventive treatment of migraine in adults who meet criteria for episodic migraine as well as results evaluating the efficacy and safety of BOTOX® (onabotulinumtoxinA) and UBRELVY® (ubrogepant).

    In addition, investigators will present the study design of the Phase 3 study assessing the efficacy and safety of the investigational treatment ABBV-951 (foslevodopa/foscarbidopa), a levodopa/carbidopa prodrug administered as a 24-hour continuous, subcutaneous infusion in people with advanced Parkinson's disease.

    Key AbbVie abstracts and presentation details for the 2021 AAN Annual Meeting program are outlined below. Posters will be available during and for 30 days following the meeting.

    Abstract Title

    Presentation Details

    All times CT

    Migraine

    Atogepant Significantly Reduces Mean Monthly Migraine Days in the Phase 3 Trial (ADVANCE) for the Prevention of Migraine

    Clinical Trials Plenary Session

    Tuesday, April 20

    9:15 a.m. CT

    Long-term Safety and Tolerability of Atogepant 60 mg Following Once Daily Dosing Over 1 year for the Preventive Treatment of Migraine

    S5: Headache 1

    Saturday, April 17

    3 p.m. CT

    Atogepant Improved Patient-Reported Migraine-Specific Quality of Life in a 12-Week Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine           

    Poster

    Atogepant Improved Patient-Reported Outcome (PRO) Measures of Activity Impairment in Migraine-Diary and Headache Impact Test in a 12-Week, Double-blind, Randomized Phase 3 (ADVANCE) Trial for Preventive Treatment of Migraine     

    Poster

    Ubrogepant Was Safe and Well Tolerated in the Acute Treatment of Perimenstrual Migraine

    S5: Headache 1

    Saturday, April 17

    3:32 p.m. CT

    Assessing Barriers to Care in Episodic and Chronic Migraine: Results From the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study

    S15: Headache 2

    Monday, April 19

    1:32 p.m. CT

    Characterizing Preventive Treatment Gaps in Migraine: Results from the CaMEO Study

    Poster

    Real-World Evidence for Control of Chronic Migraine (CM) in Patients Meeting American Headache Society (AHS) Criteria Who Received Calcitonin Gene‒Related Peptide Monoclonal Antibody (CGRPmAb) Therapy Added to OnabotulinumtoxinA Treatment

    Poster

    Real-World Evidence for Control of Patients With Chronic Migraine Who Received CGRP Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment

    Poster

    Consecutive Headache-Free Days With OnabotulinumtoxinA Treatment in Patients With Chronic Migraine: A Pooled PREEMPT Analysis

    Poster

    Real-World Safety and Efficacy of 155-195U OnabotulinumtoxinA in Participants With Chronic Migraine: Results From the REPOSE Study

    Poster

    Advanced Parkinson's Disease

    Efficacy and Safety of Subcutaneous Foslevodopa/Foscarbidopa Versus Oral Levodopa/Carbidopa in Advanced Parkinson's Disease Patients: Design of a Phase 3, Randomized, Double-blind, Double-dummy, Active Controlled 12-Week Trial    

    Poster

    Identifying Care Gaps in Parkinson's Disease Patients Eligible for Device-Aided Therapies: Results from Using the MANAGE-PD Tool in Patients from G7 Countries

    Poster

    Unmet Needs and Treatment Patterns of Advanced Parkinson's Disease Patients in the United States

    Poster

    A Retrospective Study Evaluating the Use of Anti-Parkinsonian Medications in Patients with Advanced Parkinson's Disease Who Are Treated with Levodopa-Carbidopa Intestinal Gel and Deep Brain Stimulation: The PD-DUAL Study     

    Poster

    Sustained Improvements in Motor and Non-Motor Symptoms in Advanced Parkinson's Disease Patients Treated with Carbidopa Levodopa Enteral Suspension in a 'Real-World' Study: Interim Results of the Multinational DUOGLOBE Study With at least 24 Months Follow-Up       

    Poster

    Spasticity

    Consistent Dosing Over Time and Within Treatment Interval Groups with OnabotulinumtoxinA: Analysis from the Adult Spasticity International Registry (ASPIRE)

    Poster

    A full list of all 33 AbbVie abstracts accepted for presentation at the 2021 AAN Annual Meeting can be found here.

    About Atogepant

    Atogepant is an investigational orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

    The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for atogepant. AbbVie anticipates a regulatory decision in late Q3 2021.

    About ABBV-951

    ABBV-951 (foslevodopa/foscarbidopa) is a continuous subcutaneous infusion being investigated for the treatment of advanced Parkinson's disease.

    About BOTOX®

    BOTOX® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Today, BOTOX® is FDA-approved for 12 therapeutic indications, including Chronic Migraine, overactive bladder, leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults, cervical dystonia, adult and pediatric spasticity, severe underarm sweating (axillary hyperhidrosis), and pediatric detrusor overactivity associated with a neurologic condition.

    BOTOX® (onabotulinumtoxinA) Important Information

    Indications

    BOTOX® is a prescription medicine that is injected into muscles and used:

    • To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
    • To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder caused by a neurologic disease who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication
    • To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
    • To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older
    • To treat increased muscle stiffness in people 2 years of age and older with spasticity
    • To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
    • To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older

    BOTOX® is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.

    It is not known whether BOTOX® is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

    BOTOX® has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles. 

    It is not known whether BOTOX® is safe and effective for severe sweating anywhere other than your armpits. 

    IMPORTANT SAFETY INFORMATION

    BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

    • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months
    • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing

    There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX® has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus.

    BOTOX® may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX®. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

    Do not receive BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.

    Do not receive BOTOX® for the treatment of urinary incontinence if you: have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (not being able to empty the bladder), only patients who are willing and able to initiate catheterization post treatment, if required, should be considered for treatment.

    Patients treated for overactive bladder:

    In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX® compared to 2 of the 542 treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary retention than nondiabetics. 

    Adult Patients treated for overactive bladder due to neurologic disease:

    In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection, required catheterization for urinary retention following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104) treated with placebo. The median duration of post-injection catheterization for these patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days) as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7). Among patients not using CIC at baseline, those with MS were more likely to require CIC post injection than those with SCI.

    The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.

    Serious and/or immediate allergic reactions have been reported, including itching, rash, red itchy welts, wheezing, asthma symptoms, dizziness, or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.

    Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.

    Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX® for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX®.

    Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX® for their blepharospasm, especially in people with certain nerve disorders. BOTOX® may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX®. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

    Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX® for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX®.

    Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX® for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX® for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX® for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

    Autonomic dysreflexia in patients treated for overactive bladder due to neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX® 200 Units compared with placebo (1.5% versus 0.4%, respectively).

    Tell your doctor about all your medical conditions, including if you: have or have had bleeding problems; have plans to have surgery; had surgery on your face; weakness of forehead muscles; trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence (symptoms of a urinary tract infection may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX® can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX® passes into breast milk).

    Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX® with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® in the past.

    Tell your doctor if you received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

    Other side effects of BOTOX® include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include urinary tract infection and painful urination. In children being treated for urinary incontinence, other side effects include urinary tract infection and bacteria in the urine. If you have difficulty fully emptying your bladder on your own after receiving BOTOX®, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

    For more information refer to the Medication Guide or talk with your doctor.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide.

    About UBRELVY® (ubrogepant)

    UBRELVY® (ubrogepant) is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY® is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.

    IMPORTANT SAFETY INFORMATION

    Who should not take UBRELVY® (ubrogepant)?


    Do not take UBRELVY® if you are taking medicines known as strong CYP3A4 inhibitors, such as ketoconazole, clarithromycin, itraconazole.

    What should I tell my healthcare provider before taking UBRELVY®?

    Tell your healthcare provider about all your medical conditions, including if you:

    • Have liver problems
    • Have kidney problems
    • Are pregnant or plan to become pregnant
    • Are breastfeeding or plan to breastfeed

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider can tell you if it is safe to take UBRELVY® with other medicines.

    What are the most common side effects of UBRELVY®?

    The most common side effects are nausea (4%) and sleepiness (3%). These are not all of the possible side effects of UBRELVY®.

    What is UBRELVY® (ubrogepant)?

    UBRELVY® is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY® is not used to prevent migraine headaches.

    Please see full Prescribing Information.

    About DUOPA

    DUOPA (carbidopa and levodopa) enteral suspension is a prescription medicine used for treatment of advanced Parkinson's disease. DUOPA contains two medicines: carbidopa and levodopa.

    Important Safety Information

    What is the most important safety information I should know about DUOPA?

    • Stomach and intestine (gastrointestinal) problems and problems from the procedure you will need to have to receive DUOPA (gastrointestinal procedure-related problems) may occur. Some of these problems may require surgery and may lead to death.
      • Serious side effects may include: a blockage of your stomach or intestines (bezoar); stopping movement through intestines (ileus); drainage, redness, swelling, pain, feeling of warmth around the small hole in your stomach wall (stoma); bleeding from stomach ulcers or your intestines; inflammation of your pancreas (pancreatitis); infection in your lungs (pneumonia); air or gas in your abdominal cavity; skin infection around the intestinal tube, pocket of infection (abscess), or infection in your blood (sepsis) or abdominal cavity may occur after surgery; stomach pain, nausea, or vomiting.
    • Tell your healthcare provider right away if you have any of the following symptoms of stomach and intestine problems and gastrointestinal procedure-related problems: stomach (abdominal) pain; constipation that does not go away; nausea or vomiting; fever; blood in your stool; or a dark tarry stool.

    Your healthcare provider will talk to you about the stoma procedure. Before the stoma procedure, tell your healthcare provider if you ever had a surgery or problems with your stomach.

    Talk to your healthcare provider about what you need to do to care for your stoma. After the procedure, you and your healthcare provider will need to regularly check the stoma for any signs of infection.

    Do not take DUOPA if you currently take or have recently taken (within 2 weeks) a medication for depression called a non-selective monoamine oxidase (MAO) inhibitor. Ask your healthcare provider or pharmacist if you are not sure if you take an MAO inhibitor.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using DUOPA with certain other medicines, including medications for high blood pressure, MAO inhibitors, antipsychotics, metoclopramide, isoniazid, and iron or vitamin supplements, may cause serious side effects. High-protein foods may affect how DUOPA works. Tell your healthcare provider if you change your diet.

    DUOPA may cause serious side effects. Talk to your doctor before starting DUOPA and while on DUOPA if you have had or have any of these:

    • Falling asleep during normal daily activities without warning. DUOPA may cause you to fall asleep while you are doing daily activities such as driving, which may result in an accident. This can happen as late as one year after starting DUOPA. Do not drive or operate machinery until you know how DUOPA affects you. Tell your healthcare provider if you take medicines that can make you sleepy, such as sleep medicines, antidepressants, or antipsychotics.
    • Low blood pressure when you stand or sit up quickly. After you have been sitting or lying down, stand up slowly to help reduce dizziness, nausea, sweating, or fainting until you know how DUOPA affects you.
    • Seeing, hearing, or feeling things that are not real (hallucinations).
    • Unusual urges. Some people taking medicines for Parkinson's disease, including DUOPA, have reported urges such as excessive gambling, compulsive eating, compulsive shopping, and increased sex drive.
    • Depression and suicide. DUOPA can cause or worsen depression. Pay close attention to changes in your mood, behavior, thoughts, or feelings. Call your healthcare provider right away if you feel depressed or have thoughts of suicide.
    • Uncontrolled sudden movements (dyskinesia). If you have new dyskinesia or your dyskinesia gets worse, tell your healthcare provider. This may be a sign that your dose of DUOPA or other Parkinson's medicines may need to be adjusted.
    • Progressive weakness or numbness or loss of sensation in the fingers or feet (neuropathy).
    • Heart attack or other heart problems. Tell your healthcare provider if you have experienced increased blood pressure, a fast or irregular heartbeat, or chest pain.
    • Abnormal blood tests. DUOPA may cause changes in certain blood tests, especially certain hormone and kidney function blood tests.
    • Worsening of the increased pressure in your eyes (glaucoma). The pressure in your eyes should be checked after starting DUOPA.

    Do not stop using DUOPA or change your dose unless you are told to do so by your healthcare provider. Tell your healthcare provider if you develop withdrawal symptoms such as fever, confusion, or severe muscle stiffness.

    The most common side effects of DUOPA include: complications of tubing placement procedure, swelling of legs and feet, nausea, high blood pressure (hypertension), depression, and mouth and throat pain.

    Please see the full Prescribing Information including Medication Guide for additional information about DUOPA.

    About AbbVie Leadership in Migraine

    AbbVie, a leader in the migraine space, markets BOTOX® (onabotulinumtoxinA), the first FDA-approved, preventive treatment for adults with Chronic Migraine and UBRELVY® (ubrogepant), the first FDA-approved oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), which is indicated for the acute treatment of migraine with or without aura in adults.

    About AbbVie in Neuroscience

    At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie's Neuroscience portfolio consists of approved therapies and a robust pipeline in neurological and psychiatric disorders, including Alzheimer's disease, bipolar I disorder, major depressive disorder, migraine, Parkinson's disease, spinal cord injuries, post-stroke spasticity, schizophrenia, stroke and others.

    We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people's lives.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    Cision View original content:http://www.prnewswire.com/news-releases/abbvie-to-present-data-across-its-robust-neuroscience-portfolio-at-the-2021-american-academy-of-neurology-aan-annual-meeting-301263600.html

    SOURCE AbbVie

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  3. NORTH CHICAGO, Ill., April 2, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

    As previously disclosed, AbbVie received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis. AbbVie responded to the request and the FDA has informed AbbVie that, as expected, it requires additional…

    NORTH CHICAGO, Ill., April 2, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for upadacitinib in the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

    As previously disclosed, AbbVie received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in atopic dermatitis. AbbVie responded to the request and the FDA has informed AbbVie that, as expected, it requires additional time for a full review of the submission.

    "We are confident in the sNDA and continue to work with the FDA to bring upadacitinib to patients living with moderate to severe atopic dermatitis in need of new treatment options," said Michael Severino, M.D., vice chairman and president, AbbVie.

    About RINVOQTM (upadacitinib)

    Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.

    RINVOQ U.S. Use and Important Safety Information

    RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

    What is the most important information I should know about RINVOQ?

    RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

    • Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).
    • Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
    • Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
    • Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

    What should I tell my HCP BEFORE starting RINVOQ?

    Tell your HCP if you:

    • Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
      • Fever, sweating, or chills
      • Shortness of breath
      • Warm, red, or painful skin or sores on your body
      • Muscle aches
      • Feeling tired
      • Blood in phlegm
      • Diarrhea or stomach pain
      • Cough
      • Weight loss
      • Burning when urinating or urinating more often than normal
    • Have TB or have been in close contact with someone with TB.
    • Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
    • Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
    • Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.
    • Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
    • Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.
    • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

    Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

    Especially tell your HCP if you take:

    • Medicines for fungal or bacterial infections
    • Rifampicin or phenytoin
    • Medicines that affect your immune system

    Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

    What should I tell my HCP AFTER starting RINVOQ?

    Tell your HCP right away if you:

    • Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
    • Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
      • Swelling
      • Sudden unexplained chest pain
      • Pain or tenderness in the leg
      • Shortness of breath
    • Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

    What are the common side effects of RINVOQ?

    These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

    RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

    This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

    If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

    Please click here for the Full Prescribing Information and Medication Guide.

    Globally, prescribing information varies; refer to the individual country product label for complete information.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookLinkedIn or Instagram.

    Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

     

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    SOURCE AbbVie

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  4. IRVINE, Calif., April 1, 2021 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE:ABBV), announces the launch of SkinMedica® Neck Correct Cream, the first product from the professional-grade skincare line formulated to address the specific biology of the skin on the neck and décolleté area. SkinMedica® Neck Correct Cream was designed to prevent the early signs as well as treat the visible appearance of moderate to severe neck aging.  It is clinically proven to firm and tighten the look of crepey skin, prevent and reduce the look of sagging, smooth deep lines and wrinkles and enhance skin tone evenness.1

    "The neck and décolleté area are extensions of the face but require a totally different treatment plan due to the unique biology…

    IRVINE, Calif., April 1, 2021 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE:ABBV), announces the launch of SkinMedica® Neck Correct Cream, the first product from the professional-grade skincare line formulated to address the specific biology of the skin on the neck and décolleté area. SkinMedica® Neck Correct Cream was designed to prevent the early signs as well as treat the visible appearance of moderate to severe neck aging.  It is clinically proven to firm and tighten the look of crepey skin, prevent and reduce the look of sagging, smooth deep lines and wrinkles and enhance skin tone evenness.1

    "The neck and décolleté area are extensions of the face but require a totally different treatment plan due to the unique biology of the neck skin," says Colleen McKenna, Vice President of Facial Aesthetics & SkinMedica® Marketing, Allergan Aesthetics. "Neck wrinkles are five times deeper than wrinkles on the cheeks, while sagging of the neck skin is more severe than any other part of the body. The skin of the neck is also thinner, similar to the skin on eyelids.2 When designing the SkinMedica® Neck Correct Cream, it was imperative for our R&D team to address these concerns with a multi-modal approach and develop a product with cutting edge ingredients, a cosmetically elegant texture and clinically-proven performance."

    The SkinMedica® Neck Correct Cream will launch with a digital-led campaign, #SmoothTheWay to showcase the product's performance and honor those who have smoothed the way for brighter futures for others. The team at SkinMedica® and Allergan Aesthetics acknowledges that it is a luxury to be able to use your voice for good, to break barriers and stick your neck out to better society.

    With more than two decades of excellence in innovation, SkinMedica® continues to rely on research to formulate the most advanced and innovative skincare products that deliver strong, efficacious results. The SkinMedica® Neck Correct Cream has a luxurious formula of power-house peptides, antioxidants and active botanical extracts uniquely designed to target the biological pathways specific to neck aging which include:1

    • Dermal Thickness & Skin Elasticity- Rice Protein, Shitake Mushroom Extract, Green Microalgae Extract, Lemon Balm Extract and Peptides
      • Support extracellular matrix proteins, including collagen and elastin
    • Platysma Muscle- Paracress Extract
      • Helps reduce the appearance of platysmal bands
    • Free Radical Damage- Knotgrass Extract & Dunaliella Salina Extract
      • Protects skin from free radicals

    "The neck is an instant indicator of age, and the neck is having a major moment due to the rise of patients experiencing neck related concerns from increased use of technological devices," says Dr. Mona Gohara, Dermatologist and Associate Clinical Professor, Yale School of Medicine. "Neck creams on the market have traditionally relied on ingredients to support the dermal matrix, not understanding that neck aging is a multifaceted issue. The SkinMedica® Neck Correct Cream addresses the loss of collagen and elastin, concerns of "tech neck" that contribute to not only the visible, but the intrinsic signs of neck aging. Not only will I be adding the SkinMedica® Neck Correct Cream to my regimen, but this is a product I recommend for patients spanning trans-generationally; from those in their 20s who want to proactively prejuvenate the neck region, all the way up to my patients in their 60s-80s who want to treat moderate to severe signs of neck aging."

    In clinical studies1, significant improvements were found in the visible signs of neck aging, and SkinMedica® Neck Correct Cream users reported the following:

    • At week 4, there were significant improvements in the appearance of fine lines, wrinkles, crepiness and roughness.
    • At week 8, there were significant improvements in the appearance of laxity, sagging, skin tone evenness, radiance and visible roughness.
    • At week 12, on the Neck: n=42
      • 98% reported it made their skin feel smoother
      • 93% reported overall satisfaction with the look of their neck
      • 88% reported it improved the texture of their skin
      • 86% reported it improved the overall health and look of their neck
    • At week 12, on the Décolleté: n=42
      • 98% reported it made their skin smoother and softer
      • 93% reported improved smoothness of skin

    SkinMedica® Neck Correct Cream ($135 USD MSRP) is available for purchase at SkinMedica.com, and through a network of licensed physicians and medically supervised spas. For use, gently apply to clean skin by applying one pump on your neck and one pump on your décolleté using upward strokes, morning and evening. For more information follow @SkinMedica and #SmoothTheWay on Instagram, or visit SkinMedica.Com/NeckCorrectCream.

    About Allergan Aesthetics

    At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. Our aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Our goal is to consistently provide our customers with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch. For more information, visit www.AllerganAesthetics.com.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn.

    SkinMedica® IMPORTANT SAFETY INFORMATION

    The SkinMedica® product described here is intended to meet the FDA's definition of a cosmetic product, an article applied to the human body to cleanse, beautify, promote attractiveness, and alter appearances. This SkinMedica® product is not intended to be a drug product that diagnoses, treats, cures or prevents any disease or condition. This product has not been approved by the FDA and the statements on these pages have not been evaluated by the FDA.

    For more information, please talk to your provider or visit SkinMedica.com. To report an adverse reaction, please call Allergan at 1-800-433-8871.

    References

    1. Data on file at SkinMedica®
    2. Kim E, Cho G, Won NG, Cho J. Age-related changes in skin bio-mechanical properties: the neck skin compared with the cheek and forearm skin in Korean females. Skin Res Technol. 2013;19(3):236-241.

     

    Allergan Aesthetics Logo (PRNewsfoto/AbbVie)

     

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  5. NORTH CHICAGO, Ill., April 1, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that the New England Journal of Medicine has published 24-week results from the Phase 3 SELECT-PsA 1 trial evaluating RINVOQ (upadacitinib, 15 mg and 30 mg) in adults with active psoriatic arthritis who had responded inadequately or were intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).1 These data build on previously announced Phase 3 topline results showing that upadacitinib 15 mg and 30 mg met the primary endpoint of ACR20 response at week 12 versus placebo as well as key secondary endpoints.1 

    "These data show upadacitinib's potential to improve clinical and radiographic outcomes for people with psoriatic arthritis…

    NORTH CHICAGO, Ill., April 1, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that the New England Journal of Medicine has published 24-week results from the Phase 3 SELECT-PsA 1 trial evaluating RINVOQ (upadacitinib, 15 mg and 30 mg) in adults with active psoriatic arthritis who had responded inadequately or were intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs).1 These data build on previously announced Phase 3 topline results showing that upadacitinib 15 mg and 30 mg met the primary endpoint of ACR20 response at week 12 versus placebo as well as key secondary endpoints.1 

    "These data show upadacitinib's potential to improve clinical and radiographic outcomes for people with psoriatic arthritis, a complex and progressive autoimmune disease," said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie. "Ultimately, our goal is to help more patients achieve disease control and relief from their most bothersome joint and skin symptoms that can impact their daily lives."

    Recently, the European Commission (EC) approved RINVOQ (15 mg) for use in adults with active psoriatic arthritis. Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy are under evaluation by regulatory authorities in the United States.

    Efficacy results for ranked secondary endpoints not previously reported include:1*

    • A significantly higher percentage of patients taking upadacitinib 15 mg and 30 mg (54 and 58 percent, respectively) achieved resolution of enthesitis (Leeds Enthesitis Index (LEI)=0) compared to those taking placebo (32 percent) at week 24 (p<0.001 for both doses); 47 percent of patients achieved resolution of enthesitis in the adalimumab group.
    • Patients taking upadacitinib 15 mg and 30 mg (6.3 and 7.1 mean change from baseline, respectively) saw an improvement in fatigue compared to patients taking placebo (2.8) at week 12 (p<0.001 for both doses), as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, which continued to improve through week 24; patients in the adalimumab group saw an improvement (5.7) at week 12.
    • At week 16, significantly more patients achieved a score of 0 or 1 and at least a 2-point improvement in the static Investigator Global Assessment of psoriasis (sIGA) with the 15 mg and 30 mg doses of upadacitinib (42 and 54 percent, respectively) versus placebo (11 percent, p<0.001 for both doses); 39 percent of patients in the adalimumab group.
    • Inhibition of radiographic progression, as measured by the modified total Sharp/van der Heijde Score (mTSS) at week 24, was observed with both doses of upadacitinib (-0.04 for the 15 mg dose, p<0.001, and 0.03 for the 30 mg dose, p=0.007), compared to placebo, which showed an increase of 0.25; 0.01 was observed in the adalimumab group.
    • At week 24, 77 percent and 80 percent of patients taking 15 mg and 30 mg of upadacitinib, respectively, achieved resolution of dactylitis (Leeds Dactylitis Index (LDI)=0) compared to 40 percent of patients taking placebo (nominal p-values <0.001; comparison not multiplicity controlled); 74 percent of patients achieved resolution of dactylitis in the adalimumab group.

    * Comparison to adalimumab for these endpoints was not multiplicity-controlled.

    "Psoriatic arthritis is a chronic, painful autoimmune disease," said Iain McInnes, Professor of Medicine and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK, and the lead study author. "I am encouraged by these results showing that upadacitinib can improve outcomes for people living with psoriatic arthritis who are facing the potentially debilitating impact of joint and skin symptoms, along with other debilitating challenges like fatigue."

    The safety profile of upadacitinib was generally similar to results reported previously in rheumatoid arthritis trials.1,2 Through 24 weeks, rates of treatment-emergent adverse events (AEs) and serious AEs were similar between 15 mg of upadacitinib and 40 mg of adalimumab, but were more frequent with upadacitinib 30 mg. The most common AE was upper respiratory tract infection. Rates of serious infections were 0.9 percent (placebo), 0.7 percent (adalimumab), 1.2 percent (upadacitinib 15 mg) and 2.6 percent (upadacitinib 30 mg). Herpes zoster were reported in three (0.7 percent), zero, four (0.9 percent) and five (1.2 percent) cases for the placebo, adalimumab, upadacitinib 15 mg and upadacitinib 30 mg arms, respectively. Malignancy was reported in all treatment arms with one case in the placebo and upadacitinib 15 mg arms (0.2 percent) and three cases in the adalimumab and upadacitinib 30 mg arms (0.7 percent).

    Adjudicated venous thrombotic events included one event of deep vein thrombosis in the placebo group (0.2 percent), two events of deep vein thrombosis in the adalimumab group (0.5 percent), and one event of pulmonary embolism in the upadacitinib 30 mg group (0.2 percent); no thrombotic events were reported in the upadacitinib 15 mg group. No major adverse cardiovascular events (MACE) and deaths were reported with upadacitinib treatment.1 

    About SELECT-PsA 11,3

    SELECT-PsA 1 is a Phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomized to upadacitinib 15 mg, upadacitinib 30 mg, adalimumab 40 mg EOW, or placebo followed by either upadacitinib 15 mg or upadacitinib 30 mg at week 24.

    The primary endpoint was the percentage of subjects receiving upadacitinib 15 mg or 30 mg who achieved an ACR20 response after 12 weeks of treatment versus placebo. Ranked secondary endpoints included percentage of patients achieving a static Investigator Global Assessment (sIGA) of psoriasis of 0 or 1 and at least a 2-point improvement from baseline at week 16; percentage of patients achieving PASI 75 response at week 16; inhibition of radiographic progression at week 24 per the modified total Sharp/van der Heijde Score; the percentage of patients achieving MDA at week 24; percentage of participants with resolution of enthesitis at week 24; change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire at week 12; and percentage of patients with resolution of dactylitis at week 24 versus placebo. The long-term extension of the trial is ongoing. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).

    About RINVOQ™ (upadacitinib)

    Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.2-12 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs; for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.2-5,7-12 Use of RINVOQ in psoriatic arthritis is not approved and its safety and efficacy are under evaluation by regulatory authorities.

    RINVOQ U.S. Use and Important Safety Information13

    RINVOQ is a prescription medicine used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children under 18 years of age.

    What is the most important information I should know about RINVOQ?

    RINVOQ is a medicine that can lower the ability of your immune system to fight infections. You should not start taking RINVOQ if you have any kind of infection unless your healthcare provider (HCP) tells you it is okay.

    • Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You may be at higher risk of developing shingles (herpes zoster).
    • Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
    • Blood clots in the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. This may be life-threatening and cause death.
    • Tears in the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

    What should I tell my HCP BEFORE starting RINVOQ?

    Tell your HCP if you:

    • Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as:
      • Fever, sweating, or chills
      • Shortness of breath
      • Warm, red, or painful skin or sores on your body
      • Muscle aches
      • Feeling tired
      • Blood in phlegm
      • Diarrhea or stomach pain
      • Cough
      • Weight loss
      • Burning when urinating or urinating more often than normal
    • Have TB or have been in close contact with someone with TB.
    • Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), or blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
    • Have other medical conditions including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
    • Live, have lived, or have traveled to parts of the country that increase your risk of getting certain kinds of fungal infections, such as the Ohio and Mississippi River valleys and the Southwest. If you are unsure if you've been to these areas, ask your HCP.
    • Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
    • Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose.
    • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. You should not breastfeed while taking RINVOQ and for at least 6 days after your last dose.

    Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

    Especially tell your HCP if you take:

    • Medicines for fungal or bacterial infections
    • Rifampicin or phenytoin
    • Medicines that affect your immune system

    Ask your HCP or pharmacist if you are not sure if you are taking any of these medicines.

    What should I tell my HCP AFTER starting RINVOQ?

    Tell your HCP right away if you:

    • Have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
    • Have any signs or symptoms of blood clots during treatment with RINVOQ, including:
      • Swelling
      • Sudden unexplained chest pain
      • Pain or tenderness in the leg
      • Shortness of breath
    • Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

    What are the common side effects of RINVOQ?

    These include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever. These are not all the possible side effects of RINVOQ.

    RINVOQ is taken once a day with or without food. Do not split, break, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it.

    This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

    If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

    Please click here for the Full Prescribing Information and Medication Guide.

    Globally, prescribing information varies; refer to the individual country product label for complete information.

    About HUMIRA (adalimumab) in the U.S.

    Uses14

    HUMIRA is a prescription medicine used:

    • To reduce the signs and symptoms of:
      • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
      • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
      • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
      • Ankylosing spondylitis (AS) in adults.
      • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
      • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
      • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
    • In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
    • To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
    • To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

    Important Safety Information

    HUMIRA is a TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. People should be tested for TB before HUMIRA use and monitored for signs and symptoms of TB during therapy, even if their TB test was negative. People at risk of TB may be treated with medicine for TB. Treatment with HUMIRA should not be started in a person with an active infection, unless approved by a doctor. HUMIRA should be stopped if a person develops a serious infection. People should tell their doctor if they live in or have been to a region where certain fungal infections are common, as these infections may happen or become more severe if people use HUMIRA. People should tell their doctor if they have had TB or hepatitis B, are prone to infections, or have symptoms such as fever, fatigue, cough, or sores.

    For people taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HUMIRA, the chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated.

    Other possible serious side effects with HUMIRA include hepatitis B infection in carriers of the virus; allergic reactions; nervous system problems; blood problems; certain immune reactions, including a lupus-like syndrome; liver problems; and new or worsening heart failure or psoriasis. The use of HUMIRA with anakinra or abatacept is not recommended. People using HUMIRA should not receive live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA.

    Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.

    HUMIRA is given by injection under the skin.

    The benefits and risks of HUMIRA should be carefully considered before starting therapy.

    Please click here for the Full Prescribing Information and Medication Guide.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

    Globally, prescribing information varies; refer to the individual country product label for complete information.

    About AbbVie

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookLinkedIn or Instagram.

    Forward-Looking Statements

    Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

    References:

    1. McInnes I, et al. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. New England Journal of Medicine. 2021 April 1;384:1227-1239. doi: 10.1056/NEJMoa2022516.
    2. Burmester GR, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
    3. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on November 30, 2020.
    4. A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (SELECT-PsA 2). Clinicaltrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104374. Accessed on November 30, 2020.
    5. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on November 30, 2020.
    6. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on November 30, 2020.
    7. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on November 30, 2020.
    8. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on November 30, 2020.
    9. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on November 30, 2020.
    10. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on November 30, 2020.
    11. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on November 30, 2020.
    12. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed on November 30, 2020.
    13. RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
    14. HUMIRA Injection [Package Insert]. North Chicago, Ill.: AbbVie Inc.

     

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