ABBV AbbVie Inc.

131.98
-1.05  -1%
Previous Close 133.03
Open 133.06
52 Week Low 101.8117
52 Week High 138.15
Market Cap $233,324,863,771
Shares 1,767,880,465
Float 1,766,357,743
Enterprise Value $301,796,863,770
Volume 7,578,136
Av. Daily Volume 6,424,751
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Upcoming Catalysts

Drug Stage Catalyst Date
VENCLEXTA (venetoclax) - CANOVA
Relapsed or refractory multiple myeloma
Phase 3
Phase 3
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RINVOQ (upadacitinib)
Active Ankylosing Spondylitis
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
SKYRIZI (risankizumab) - (KEEPSAKE2)
Psoriatic Arthritis
Approved
Approved
Approved January 21, 2022.
SKYRIZI (risankizumab)
Psoriatic Arthritis
Approved
Approved
Approved January 21, 2022.
RINVOQ (Upadacitinib)
Atopic Dermatitis
Approved
Approved
Approved January 14, 2022.
IMBRUVICA (Ibrutinib)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 primary endpoint not met (PFS/OS).
Venetoclax Plus Daratumumab and Dexamethasone
Multiple Myeloma
Phase 1/2
Phase 1/2
Phase 1/2 safety and preliminary efficacy data reported that treatment of patients with t(11;14) RRMM using VenDd and those with RRMM with VenDvd demonstrated a tolerable safety profile and an overall response rate (ORR) of 95.8% and 91.7%, respectively, noted December 13, 2021.
Venetoclax
Multiple myeloma
Phase 3
Phase 3
Phase 3 overall survival results reported that there were 78 (40%) deaths in the treatment arm versus 36 (37%). Median OS was not reached in the treatment or placebo arm among all patients, noted December 13, 2021.
RINVOQ (upadacitinib) - (SELECT-AXIS 2)
Non-radiographic axial spondyloarthritis
sNDA Filing
sNDA Filing
sNDA submitted to FDA January 7, 2021.
RINVOQ (Upadacitinib)
Ulcerative Colitis (maintenance)
Phase 3
Phase 3
Phase 3 trial met primary and all secondary endpoints - June 29, 2021.
RINVOQ (Upadacitinib) - U-ACHIEVE
Ulcerative colitis
NDA Filing
NDA Filing
NDA filed September 16, 2021.
VRAYLAR (cariprazine)
Major depressive disorder
Phase 3
Phase 3
Phase 3 study 3111-301-001 met primary endpoint and demonstrated statistically significant change from baseline to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared with placebo. However, study 3111-302-001 did not meet its primary endpoint, noted October 29, 2021.
Depatuxizumab mafodotin (ABT-414)
Glioblastoma (rGBM)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint at interim analysis - May 17, 2019.
IMBRUVICA (Ibrutinib) - (SHINE)
Mantle Cell Lymphoma
Phase 3
Phase 3
Phase 3 trial ongoing.
IMBRUVICA (ibrutinib)
Diffuse large B-cell lymphoma (DLBCL)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 11, 2018.
IMBRUVICA (Ibrutinib) and prednisone
Chronic Graft Versus Host Disease
Phase 3
Phase 3
Phase 3 trial ongoing.
RINVOQ (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. Phase 3b data displayed among the 32 patients who did not achieve EASI 75 on dupilumab, 88 percent, 69 percent and 22 percent of those patients achieved EASI 75, EASI 90 and EASI 100, respectively, after 16 weeks on upadacitinib, noted September 30, 2021.
SKYRIZI (risankizumab) - MOTIVATE
Crohn’s Disease
NDA Filing
NDA Filing
NDA submission to FDA for the treatment of patients 16 years and older with moderate to severe Crohn's disease, September 20, 2021.
SKYRIZI (risankizumab) vs COSENTYX (secukinumab)
Plaque psoriasis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 14, 2020.
ABBV-951 (foslevodopa/foscarbidopa)
Parkinson's disease
Phase 3
Phase 3
Phase 3 data reported that trial met primary endpoint, and was statistically superior to oral levodopa/carbidopa in reducing motor fluctuations, noted October 28, 2021.
Nirogacestat in combination ABBV-383
Relapsed/Refractory Multiple Myeloma.
Phase 1b
Phase 1b
Phase 1b expected to be initiated 1H 2022.
telisotuzumab vedotin (Teliso-V)
Nonsquamous non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 ongoing, FDA granted Breakthrough Therapy Designation (BTD), noted January 4, 2021.
Cenicriviroc (CVC)
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
Phase 3 trial was terminated noted February 4, 2021.
RINVOQ (Upadacitinib)
Psoriatic arthritis
Approved
Approved
Approved December 15, 2021.
IMBRUVICA (Ibrutinib) + VENCLEXTA - Venetoclax (GLOW)
Chronic Lymphocytic Leukemia
Phase 3
Phase 3
Phase 3 data presented at ASH December 11, 2021.
RINVOQ (upadacitinib) - (U-EXCEED)
Crohn's disease (induction/maintenance)
Phase 3
Phase 3
Phase 3 data reported that trial met primary and key secondary endpoints, noted December 6, 2021.
VENCLEXTA (venetoclax) and GAZYVA (obinutuzumab)
Chronic Lymphocytic Leukemia
Approved
Approved
FDA approval announced May 15, 2019.
VUITY
Presbyopia
Approved
Approved
Approved October 29, 2021.
QULIPTA (Atogepant)
Chronic migraine
Approved
Approved
Approved September 28, 2021.
UBRELVY (Ubrogepant)
Migraine
Approved
Approved
FDA Approval announced December 23, 2019. Oral presentation of additional data September 11, 2021.
BOTOX
Upper Limb Spasticity
Approved
Approved
FDA approval announced July 29, 2021.
DALVANCE (dalbavancin)
Acute bacterial skin and skin structure infections (ABSSSI) - pediatric
Approved
Approved
FDA approval announced July 23, 2021.
ABICIPAR
Age-related macular degeneration (AMD)
CRL
CRL
CRL issued June 26, 2020.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved
Approved September 14, 2017.
VRAYLAR (cariprazine)
Maintenance Treatment of Schizophrenia
Approved
Approved
Approval announced November 13, 2017.
BOTOX
Lower limb spasticity
Approved
Approved
FDA Approval announced October 24, 2019.
BOTOX
Upper limb spasticity
Approved
Approved
FDA Approval announced June 21, 2019.
BOTOX
Neurogenic Detrusor Overactivity
Approved
Approved
FDA approval announced February 10, 2021.
BOTOX
Forehead lines
Approved
Approved
Approval (third indication) announced October 3, 2017.
JUVÉDERM VOLUMA
Mid-Face Injection Via Cannula
Approved
Approved
FDA Approval announced September 3, 2019.
SKYRIZI (risankizumab)
Psoriasis
Approved
Approved
FDA approval announced April 23, 2019.
ORILISSA (Elagolix)
Uterine Fibroids
Approved
Approved
FDA approval announced May 29, 2020.
ORILISSA (Elagolix)
Endometriosis
Approved
Approved
FDA approval announced July 24, 2018.
GLECAPREVIR / PIBRENTASVIR (G/P)
Hepatitis C virus (HCV)
Approved
Approved
Approval announced August 3, 2017.
RINVOQ (Upadacitinib)
Rheumatoid arthritis
Approved
Approved
FDA Approval announced August 16, 2019.
IMBRUVICA (Ibrutinib)
Relapsed or refractory MCL mantle cell lymphoma
Approved
Approved
Approved November 13, 2013.
VENCLEXTA (venetoclax) (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Approved
Approved
Approval announced June 11, 2018.
VENCLEXTA (venetoclax)
First line unfit AML
Approved
Approved
FDA approval announced November 21, 2018.
VENCLEXTA (venetoclax) - (VIALE-A)
Acute Myeloid Leukemia (AML)
Approved
Approved
FDA approval announced October 16, 2020.
IMBRUVICA (Ibrutinib)
Second-line Chronic graft-versus-host disease (GVHD)
Approved
Approved
Approval announced August 2, 2017.
IMBRUVICA (Ibrutinib)
Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Approved
Approved
Approved February 12, 2014.
IMBRUVICA (Ibrutinib)
Marginal zone lymphoma
Approved
Approved
sNDA filing announced September 26, 2017. Priority Review. Approved January 19, 2017.
IMBRUVICA (ibrutinib) and RITUXAN (rituximab)
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Approved
Approved
FDA Approval announced April 21, 2020.
IMBRUVICA (Ibrutinib) and GAZYVA (Obinutuzumab)
Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
Approved
Approved
FDA approval announced January 28, 2019.
IMBRUVICA (Ibrutinib)
Waldenström’s Macroglobulinemia
Approved
Approved
Approved January 29, 2015 - PCYC
JUVÉDERM VOLUMA
Augmentation of the chin region
Approved
Approved
FDA Approval announced June 15, 2020.
Oxymetazoline HCl cream 1.0%
Facial Erythema (Redness) Associated with Rosacea
Approved
Approved
Approved January 19, 2017.
IMBRUVICA (ibrutinib)
Waldenström’s Macroglobulinemia
Approved
Approved
FDA approval announced August 27, 2018.
VIEKIRA PAK
HCV - genotype 1
Approved
Approved
Approved December 19, 2014.

Latest News

  1. NORTH CHICAGO, Ill., Jan. 21, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis.1,4-7

    The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of SKYRIZI in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).2,3 Across the two Phase 3 studies, SKYRIZI met the primary…

    NORTH CHICAGO, Ill., Jan. 21, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis.1,4-7

    The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of SKYRIZI in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).2,3 Across the two Phase 3 studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints.2,3

    "Patients often do not suspect a connection between their psoriasis skin symptoms and the joint pain, swelling and stiffness they may be experiencing, potentially leading to a delay in diagnosis and treatment of psoriatic arthritis," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We're proud to expand the use of SKYRIZI to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms."

    SKYRIZI maintains a dosing regimen for PsA that is consistent with the existing regimen for moderate to severe plaque psoriasis patients – a single 150 mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4) – and can be administered alone or in combination with DMARDs.1

    "In the pivotal KEEPsAKE trials, SKYRIZI demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis," said Alan J. Kivitz, M.D., CPI, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Duncansville, Pa. and KEEPsAKE clinical trial investigator. "This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis, alongside a quarterly dosing schedule that may fit their patients' lifestyle."

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

    Highlights from the Pivotal Phase 3 Program1,2,3

    • In KEEPsAKE-1 and KEEPsAKE-2, 57.3 percent and 51.3 percent of patients receiving SKYRIZI achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 percent and 26.5 percent receiving placebo. SKYRIZI also demonstrated improvements in ACR50 and ACR70 responses compared to placebo at week 24.
    • SKYRIZI showed improvements in other key manifestations of PsA compared to placebo at week 24, including improvements in dactylitis and enthesitis for patients with pre-existing dactylitis and enthesitis.
    • Patients with coexistent plaque psoriasis receiving SKYRIZI saw improvements in the skin lesions of psoriasis, compared to placebo, as measured by the Psoriasis Area Severity Index (PASI 90) at week 24.
    • SKYRIZI showed a statistically significant improvement in physical function, compared to placebo, as measured by the Health Assessment Questionnaire-Disability Index at week 24, with a mean difference of 0.20 in KEEPsAKE-1 and 0.16 in KEEPsAKE-2.

    Safety1

    • The overall safety profile observed in patients with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in patients with plaque psoriasis.
    • SKYRIZI may cause serious side effects, including:
      • Serious Allergic Reactions: Stop using SKYRIZI and get medical help right away if you get any symptoms of a serious allergic reaction.
      • Infections: SKYRIZI may increase your risk of infections. Before starting treatment, your doctor should check you for infections and tuberculosis. Tell your doctor right away if you have an infection or symptoms of one.

                      Do not take SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.



                      Also, tell your doctor if you plan to or recently received a vaccine.

    Patient Access and Support

    AbbVie is committed to helping people access SKYRIZI and other medicines, including offering a patient support program and co-pay card that may reduce out-of-pocket costs to as little as $5 per month for eligible, commercially-insured patients. For those with health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides SKYRIZI at no charge to those who qualify. More information about this assistance program can be found at www.AbbVie.com/myAbbVieAssist.

    About Psoriatic Arthritis

    Psoriatic arthritis (PsA) is a heterogeneous, systemic inflammatory disease involving the joints and skin.5 In PsA, the immune system causes inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.5,6 PsA affects about 30 percent of patients with psoriasis.4-7

    About KEEPsAKE-1 and KEEPsAKE-22,3

    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 in the open-label extension. 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. Some of the ranked secondary endpoints included change from baseline in Health Assessment Questionnaire-Disability Index and the achievement of PASI 90 at week 24. The studies are ongoing, and patients in the long-term extension remain blinded to the original randomized allocation for the duration of the study, which will 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 on www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).

    About SKYRIZI® (risankizumab-rzaa)

    SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.8 SKYRIZI is approved in the U.S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults. The approved dose for SKYRIZI is 150 mg (one 150 mg pre-filled pen or pre-filled syringe) administered by subcutaneous injection at weeks 0 and 4, and every 12 weeks thereafter. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.9-17

    SKYRIZI U.S. Uses and Important Safety Information1

    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).
    • Active psoriatic arthritis (PsA).

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

    SKYRIZI is a prescription medication that may cause serious side effects, including:  

    Serious Allergic Reactions: Stop using SKYRIZI and get emergency help right away if you get any of the following symptoms of serious allergic reaction:

    • Fainting, dizziness, feeling lightheaded (low blood pressure)
    • Swelling of your face, eyelids, lips, mouth, tongue, or throat
    • Trouble breathing or throat tightness
    • Chest tightness
    • Skin rash, hives
    • Itching

    Infections: SKYRIZI 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

    Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI.

    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). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
    • 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, feeling tired, fungal skin infections, headache, 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.

    SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.

    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 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. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
    2. Kristensen L.E., et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase2 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2021; 0:1–7. doi: 10.1136/annrheumdis-2021-221019.
    3. Östör A., et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2021; 0:1–8. doi: 10.1136/annrheumdis-2021-221048.
    4. 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.
    5. Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
    6. 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 December 15, 2021.
    7. Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on December 15, 2021.
    8. Duvallet E., Sererano L., Assier E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011. Nov 43(7):503-11.
    9. BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02684370. Accessed on December 14, 2021.
    10. BI 655066 Versus Placebo & Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02684357. Accessed on December 14, 2021.
    11. BI 655066 / ABBV-066 (Risankizumab) in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02672852. Accessed on December 14, 2021.
    12. BI 655066/ABBV-066 (Risankizumab) Compared to Active Comparator (Adalimumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02694523. Accessed on December 14, 2021.
    13. A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on December 14, 2021.
    14. A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03398135. Accessed on December 14, 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. Available at: https://clinicaltrials.gov/ct2/show/NCT03398148. Accessed on December 14, 2021.
    16. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT03675308. Accessed on December 14, 2021.
    17. BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on December 14, 2021.

     

    Cision View original content:https://www.prnewswire.com/news-releases/us-fda-approves-second-indication-for-skyrizi-risankizumab-rzaa-to-treat-adults-with-active-psoriatic-arthritis-301466021.html

    SOURCE AbbVie

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  2. NORTH CHICAGO, Ill., Jan. 14, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg.1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.1

    "Early in my career…

    NORTH CHICAGO, Ill., Jan. 14, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg.1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.1

    "Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions." 

    The FDA approval is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies. Approximately 52 percent of the patients had prior exposure to systemic atopic dermatitis treatment. These studies evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis.2-3

    "Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching," said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City.* "In clinical trials, upadacitinib showed a robust response across skin and itch symptoms that may help evolve treatment goals for those who have not achieved adequate control of their disease. And as an oral pill with two dose strengths, upadacitinib is a welcome addition to the toolbox of clinicians who are striving to make a significant difference for their patients with moderate to severe atopic dermatitis."

    Clinical Response at Week 161-3    

    • Across the three atopic dermatitis pivotal studies, RINVOQ (15 mg and 30 mg, once daily) monotherapy and with topical corticosteroids met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance (EASI 90 and 100).

    Week 16 Data



    Measure Up 1 (MU1)

    Measure Up 2 (MU2)

    AD Up (AU)



     

    RINVOQ

    15 mg

     

    (n=281)

     

     

    RINVOQ

    30 mg

     

    (n=285)

     

     

    Placebo



     

    (n=281)

     

     

    RINVOQ

    15 mg



    (n=276)

     

     

    RINVOQ

    30 mg

     

    (n=282)

     

     

    Placebo



     

    (n=278)

     

     

    RINVOQ

    15 mg

    plus TCS

    (n=300)

     

     

    RINVOQ

    30 mg

    plus TCS

    (n=297)

     



    Placebo

    plus TCS



    (n=304)

    EASI 75*

    70%

    80%

    16%

    60%

    73%

    13%

    65%

    77%

    26%

    vIGA-AD 0/1*

    48%

    62%

    8%

    39%

    52%

    5%

    40%

    59%

    11%

    EASI 90

    53%

    66%

    8%

    42%

    58%

    5%

    43%

    63%

    13%

    EASI 100

    17%

    27%

    2%

    14%

    19%

    1%

    12%**

    23%

    1%

    Worst Pruritus NRS ≥4

    52%

    60%

    12%

    42%

    60%

    9%

    52%

    64%

    15%

    *Co-primary endpoints were EASI 75 and vIGA-AD 0/1 at week 16. Not all secondary endpoints are shown.

    **Endpoint not controlled for multiplicity.

    EASI 75 is defined as at least a 75 percent reduction in Eczema Area and Severity Index. EASI 90 and 100 are defined as at least 90 percent or 100 percent reduction in Eczema Area and Severity Index.

    vIGA-AD 0/1 is defined as a validated Investigator Global Assessment for Atopic Dermatitis of clear or almost clear (0/1) with at least two grades of reduction from baseline.

    Worst Pruritus NRS ≥4 is defined as the proportion of subjects achieving an improvement in Worst Pruritus Numerical Rating Scale (NRS) ≥4 for subjects with Worst Pruritus NRS score ≥4 at baseline.

    Itch Reduction1-3

    • In all three studies, a significant improvement in itch (Worst Pruritus NRS ≥4) was observed as early as week one, compared to placebo.

    Safety1-3

    • Overall, the safety profile observed in patients with atopic dermatitis treated with RINVOQ 15 mg or 30 mg was similar to the safety profile observed in patients with rheumatoid arthritis. Other specific adverse reactions reported in atopic dermatitis patients included eczema herpeticum/Kaposi's varicelliform eruption.
    • RINVOQ may cause serious side effects, including:
      • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while 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.
      • Increased risk of death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.
      • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers, including lymphoma, skin, and lung cancer, as these can happen. Current or past smokers are at higher risk.
      • Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor, especially in current or past smokers.
      • Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. This has happened more often in people 50 years and older with at least 1 heart disease (cardiovascular) risk factor.

    Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ.

    Other serious side effects include serious allergic reactions, tears in the stomach or intestines and changes in certain laboratory test results.

    Patient Access and Support

    AbbVie is committed to helping people access RINVOQ and other medicines, including offering a patient support program and a co-pay card that may reduce out-of-pocket costs to as little as $5 per month for eligible, commercially-insured patients. For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ at no charge to those who qualify. More information about this assistance program can be found on www.AbbVie.com/myAbbVieAssist.  

    The Impact of Atopic Dermatitis

    Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching that leads to cracked, scaly and oozing skin.4-6 It affects an estimated 7 percent of adults and 12 percent of adolescents in the U.S., with approximately 40 percent of adults experiencing moderate to severe disease.7-8 It manifests differently across individuals, with symptoms posing significant physical, psychological and economic burdens.4-5,9

    "Every person with atopic dermatitis has a unique experience with their disease, and in turn, must have multiple options to choose from in their journey to find a treatment that meets their individual needs," said Julie Block, president and chief executive officer, National Eczema Association. "This approval is a significant milestone for our community, providing an additional therapy that may bring relief to those living with the devastating symptoms of moderate to severe atopic dermatitis."   

    About RINVOQ® (upadacitinib)

    Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.10 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.1 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

    In the U.S., RINVOQ 15 mg and 30 mg is approved for use in adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.1 RINVOQ 15 mg is also approved in the U.S. for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. In the EU, RINVOQ 15 mg is approved for the treatment of adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis.

    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. 11-18 

    RINVOQ® (upadacitinib) U.S. Use and Important Safety Information1

    RINVOQ is a prescription medicine used to treat:

    • Adults with moderate to severe rheumatoid arthritis when 1 or more tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.
    • Adults with active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blockers have been used and 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 with juvenile idiopathic arthritis or psoriatic arthritis.

    • Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) who did not respond to previous treatment and whose eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended.

    RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

    It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

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

    RINVOQ may cause serious side effects, including:

    • Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while 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 healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
    • Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
    • Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer.  Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
    • Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
    • Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
    • Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
    • Tears in the stomach or intestines and changes in certain laboratory tests. 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.

    Do not take RINVOQ if:

    • You are allergic to upadacitinib or any of the ingredients in RINVOQ.

    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.
    • Are a current or past smoker.
    • Have had a heart attack, other heart problems, or stroke.
    • Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), 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, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of 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 during treatment with RINVOQ and for 4 weeks after your last dose.
    • Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 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

    If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.  

    What should I do or 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
    • Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
      • Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
      • Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
      • Pain or discomfort in your arms, back, neck, jaw, or stomach
      • Shortness of breath with or without chest discomfort
      • Breaking out in a cold sweat
      • Nausea or vomiting
      • Feeling lightheaded
      • Weakness in one part or on one side of your body
      • Slurred speech
    • Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:
      • Swelling
      • Pain or tenderness in one or both legs
      • Sudden unexplained chest or upper back pain
      • Shortness of breath or difficulty breathing
    • Tell your HCP right away if you 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), shingles (herpes zoster), herpes simplex virus infections, including cold sores, bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, low white blood cell count (neutropenia), muscle pain, and flu-like illness.

    Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.

    These are not all the possible side effects of RINVOQ.

    How should I take 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. RINVOQ is available in 15 mg and 30 mg extended-release tablets.

    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 of AbbVie's acquisition of Allergan plc ("Allergan"), failure to 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. 

    *Emma Guttman-Yassky, M.D., Ph.D., is a researcher/consultant for AbbVie.

    References:

    1. RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
    2. Guttman-Yassky E., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021; 397(10290): 2151-2168. doi:10.1016/S0140-6736(21)00588-2.
    3. Reich, Kristian et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021; 397(10290): 2169 – 2181. doi:10.1016/S0140-6736(21)00589-4.
    4. Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16.
    5. Weidinger S., et al. Atopic dermatitis. Nat Rev Dis Primers 4, 1 (2018). https://doi.org/10.1038/s41572-018-0001-z.
    6. University of Michigan Medicine. Atopic Dermatitis (Eczema). 2020. Available at: https://www.uofmhealth.org/health-library/hw216104#hw216107. Accessed on December 10, 2021.
    7. Silverberg JI. Public Health Burden and Epidemiology of Atopic Dermatitis. Dermatol Clin. 2017;35(3):283-289.
    8. Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic Dermatitis in America Study: A Cross-Sectional Study Examining the Prevalence and Disease Burden of Atopic Dermatitis in the US Adult Population. J Invest Dermatol. 2019;139(3):583-590.
    9. Eichenfield L.F., et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010.
    10. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on December 10, 2021.
    11. A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on December 10, 2021.
    12. Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) (Measure Up 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03569293. Accessed on December 10, 2021.
    13. 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. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on December 10, 2021.
    14. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on December 10, 2021.
    15. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03345836. Accessed on Accessed on December 10, 2021.
    16. A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on December 10, 2021.
    17. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on December 10, 2021.
    18. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on December 10, 2021.

     

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  3. NORTH CHICAGO, Ill., Jan. 11, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) is confirming prior revenue guidance of greater than $15 billion in combined Rinvoq (upadacitinib) and Skyrizi (risankizumab) risk-adjusted sales in 2025. AbbVie now expects 2025 risk-adjusted sales of greater than $7.5 billion for Rinvoq and greater than $7.5 billion for Skyrizi. The new Rinvoq sales guidance is the result of lower expected Rinvoq sales in the U.S. following the recent label updates in approved indications, partially offset by higher anticipated sales in international markets, as well as higher anticipated global sales in Crohn's disease and ulcerative colitis following positive Phase 3 study readouts. The updated Skyrizi sales guidance is based on continued…

    NORTH CHICAGO, Ill., Jan. 11, 2022 /PRNewswire/ -- AbbVie (NYSE:ABBV) is confirming prior revenue guidance of greater than $15 billion in combined Rinvoq (upadacitinib) and Skyrizi (risankizumab) risk-adjusted sales in 2025. AbbVie now expects 2025 risk-adjusted sales of greater than $7.5 billion for Rinvoq and greater than $7.5 billion for Skyrizi. The new Rinvoq sales guidance is the result of lower expected Rinvoq sales in the U.S. following the recent label updates in approved indications, partially offset by higher anticipated sales in international markets, as well as higher anticipated global sales in Crohn's disease and ulcerative colitis following positive Phase 3 study readouts. The updated Skyrizi sales guidance is based on continued strong performance in psoriasis.

    Forward-Looking Statements and Other Notices

    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, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to effectively integrate Allergan's business, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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.

    Rinvoq has not been approved by the U.S. Food and Drug Administration (FDA) for use in atopic dermatitis or ankylosing spondylitis and AbbVie's regulatory applications for these indications are currently under review. Rinvoq has not been approved by the FDA or European Medicines Agency (EMA) for use in ulcerative colitis, Crohn's disease, or non-radiographic axial spondyloarthritis. AbbVie's regulatory applications for Rinvoq in ulcerative colitis and non-radiographic axial spondyloarthritis are currently under review by the FDA and EMA. Skyrizi has not been approved by the FDA for use in psoriatic arthritis and AbbVie's regulatory application for this indication is currently under review. Skyrizi has not been approved by the FDA or EMA for use in Crohn's disease or ulcerative colitis. AbbVie's regulatory applications for Skyrizi in Crohn's disease are currently under review by the FDA and EMA.

    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.

    Cision View original content:https://www.prnewswire.com/news-releases/abbvie-confirms-guidance-of-greater-than-15-billion-in-combined-risk-adjusted-sales-for-rinvoq-and-skyrizi-in-2025-301457613.html

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  4. LOS ANGELES, Jan. 11, 2022 /PRNewswire/ -- ACELYRIN, INC., a biopharma company focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating development and commercialization of promising drug candidates, today announced the appointment of Melanie Gloria, BSN, as the company's chief operating officer (COO). In this role, Ms. Gloria will oversee business operations across the company.

    A former oncology nurse, Ms. Gloria has two decades' experience in the biotechnology industry having led a variety of research and development (R&D) functions. She is an experienced people leader who has managed large, diverse teams that achieved global approvals for blockbuster and life-saving therapies at Abbott (NYSE:ABT), AbbVie (NYSE:ABBV), and Horizon Therapeutics (NASDAQ:HZNP). Before joining ACELYRIN, she was senior vice president of development operations at Horizon. 

    "On behalf of the entire ACELYRIN leadership team, I am delighted to welcome Melanie as our chief operating officer. She joins us with a strong operational background and has led a variety of R&D functions in multiple therapeutic areas," said Shao-Lee Lin, M.D., Ph.D., co-founder and chief executive officer of ACELYRIN. "Her business operations, healthcare, and leadership experience will benefit ACELYRIN and our patients as we pursue our vision of bringing life-changing therapies to those with serious diseases."

    "I am thrilled to join ACELYRIN and this team of passionate colleagues as we work together to change patients' lives with innovative drug therapies," said Ms. Gloria. "I look forward to working with Shao-Lee, our board, and leadership team to build our organization and drive growth for our company and our investors. In addition to business strategy and operations and R&D, I'm passionate about mentoring and supporting others to achieve their highest aspirations. The culture of 'Courageous Caring' at ACELYRIN offers the ideal environment for this style of leadership."

    Ms. Gloria's leadership experience in business operations and clinical development spans multiple therapeutic areas, including cardiovascular, immunology, inflammation, ophthalmology, oncology, virology, and women's health. Throughout her career at Abbott, AbbVie, and Horizon, she has enabled global approvals of therapies including HUMIRA®, Viekera Pak®, Mavyret®, Skyrizi®, Rinvoq®, TEPEZZA®, and ORILISSA®.

    Ms. Gloria was named one of PharmaVOICE's 100 Most Inspiring People, received the Crain's Notable Women in Health Care award, and is a Healthcare Businesswomen's Association Luminary award recipient. She serves on the board of directors for Lake County Haven, an organization that empowers homeless women and their children to achieve permanent, independent living. She received a bachelor of science degree in nursing from the University of Illinois, Chicago.

    About ACELYRIN

    ACELYRIN, INC. is a biopharma company focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating development and commercialization of promising drug candidates and leveraging its expertise to rapidly advance these medicines to patients. For more information, please visit www.acelyrin.com.

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  5. VANCOUVER, BC, Jan. 10, 2022 /PRNewswire/ -- USA News Group  -  Nearly 10% of the estimated ~1.9 million new cancer cases in the USA will be diagnosed as leukemia, lymphoma and myeloma. According to analysts at Markets and Markets, the leukemia therapeutics market is projected to reach US$17.1 billion by 2024, growing at a CAGR of 6.8%. Along the way, there have been several positive developments in the fight against blood cancers including more recent updates from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), AbbVie Inc. (NYSE:ABBV), Novartis AG (NYSE:NVS), Thermo Fisher Scientific Inc. (NYSE:TMO), and NeoGeonomics, Inc. (NASDAQ:NEO).

    Through treatment with its flagship immunotherapeutic agent pelareorep, Oncolytics Biotech Inc. (NASDAQ…

    VANCOUVER, BC, Jan. 10, 2022 /PRNewswire/ -- USA News Group  -  Nearly 10% of the estimated ~1.9 million new cancer cases in the USA will be diagnosed as leukemia, lymphoma and myeloma. According to analysts at Markets and Markets, the leukemia therapeutics market is projected to reach US$17.1 billion by 2024, growing at a CAGR of 6.8%. Along the way, there have been several positive developments in the fight against blood cancers including more recent updates from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), AbbVie Inc. (NYSE:ABBV), Novartis AG (NYSE:NVS), Thermo Fisher Scientific Inc. (NYSE:TMO), and NeoGeonomics, Inc. (NASDAQ:NEO).

    Through treatment with its flagship immunotherapeutic agent pelareorep, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) recently announced preclinical data demonstrating the drug's synergistic anti-leukemic effects when combined with the chemotherapeutic agent azacytidine.

    "These compelling preclinical findings, together with previously reported data demonstrating clinical proof-of-concept in multiple myeloma, indicate that pelareorep's immunotherapeutic effects extend across multiple hematological malignancies," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "They also further highlight pelareorep's potential to enhance the efficacy of a wide range of cancer therapeutics and have stimulated interest in investigator-sponsored clinical studies of pelareorep in leukemia."

    Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments, as indicated with these latest preclinical results.

    Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant reduction (p<0.01) in tumor burden in a leukemia xenograft mouse model.

    Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant (p<0.001) synergistic enhancement of anti-leukemic activity against AML cell lines, a benefit that was confirmed in AML patient samples in vitro.

    The combination of pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses such as IFNβ1, BATF2, IL-12β, CCL2, TLR3, and PD-L1.

    The intravenously delivered pelareorep induces anti-cancer immune responses and promotes an inflamed tumor phenotype—turning "cold" tumors "hot"—through innate and adaptive immune responses to treat a variety of cancers.

    Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards a registration study in metastatic breast cancer.

    For certain leukemia patients, new research is confirming long remissions after treatment with the drug ibrutinib from AbbVie Inc. (NYSE:ABBV) along with chemotherapy.

    The study involved 85 patients (all 65 or younger) with chronic lymphocytic leukemia (CLL), with 46 patients exhibiting more aggressive, unmutated IGHV subtype of the disease.

    "Patients with lower-risk CLL, which is marked by mutated IGHV genes, can gain long remissions from a six-month regimen known as FCR – for the chemotherapy drugs fludarabine and cyclophosphamide and the antibody therapy rituximab," said Dr. Matthew Davids, of Dana-Farber Cancer Institute in Boston. "Our study examined whether a time-limited course of ibrutinib given in combination with FCR can provide lasting remissions for patients with CLL regardless of whether they have the IGHV-mutated or -unmutated subtype."

    The study's participants received ibrutinib for seven days, followed by a combination of ibrutinib and FCR for up to six months. They continued to receive ibrutinib alone for two more years, and stopped taking the drug when they had no detectable leukemia cells in their bone marrow after the two years.

    Novartis AG (NYSE:NVS) is moving forward with its cancer development efforts, having recently shared positive results from two ongoing trials for lymphoma and leukemia.

    During the company's Phase III ASCEMBL study of Scemblix (asciminib) on patients diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, the drug showed that it was able to hold out longer before a follow up is needed compared to Bosulif (bosutinib). 

    In comparison, Scemblix delivered a major molecular response (MMR) rate of 29.3% at 48 weeks versus 13% for those who received Bosulif.

    The findings at week 48 were consistent with a doubling of the drug's efficacy at week 4, where it logged a 25% MMR against Bosulif's 13%. In addition, patients experienced fewer adverse reactions in the Scemblix group at 7.1% versus 25%. 

    Novartis also announced that its candidate drug for relapsed or refractory follicular lymphoma (FL), Kymriah (tisagenlecleucel), showed strong efficacy during the follow-up around 17 months from the Phase II ELARA trial.

    Researchers found that Kymriah delivered high rates of durable responses in the majority of high-risk disease subgroups who, otherwise, would have a poor diagnosis. Novartis already submitted applications for approval with EU and U.S. regulators in October. Once approved, the company will elevate its research to the real-world setting. 

    A leading provider of cancer-focused genetic testing services and global oncology contract research services providers NeoGeonomics, Inc. (NASDAQ:NEO) recently announced they will use the Ion Torrent Genexus System, from Thermo Fisher Scientific Inc. (NYSE:TMO).

    The Ion Torrent Genexus System is the first turnkey next-generation sequencing (NGS) solution that automates the specimen-to-report workflow to deliver results in as little as a single day

    "We have worked with Thermo Fisher Scientific in multiple genomic initiatives and are excited to leverage their Genexus System to deliver comprehensive genomic data with unprecedented speed," said Mark Mallon, CEO of NeoGenomics. "By compressing turnaround time for results from weeks to days we can ensure researchers have the data they need to accelerate progress as they look to develop critically needed myeloid cancer treatments in the future."

    As part of the preclinical research investigation, NeoGenomics will receive early access to Thermo Fisher's new Oncomine Myeloid Assay GX v2 to validate the assay on the Genexus System. The assay is designed to optimize variant detection, covering key genes and fusions across the myeloid cancer spectrum.

    "Myeloid cancers such as acute myeloid leukemia present unique challenges due to their heterogeneity and sample complexity," said Garret Hampton, president of clinical sequencing and oncology, Thermo Fisher Scientific. "NGS allows researchers to profile all key mutations simultaneously, saving time compared to sequential single-gene testing. By combining the speed of the Genexus System with NeoGenomics' expertise and data services, we hope to advance discoveries that will inform future therapeutic development for patients who desperately need new treatment options."

    For more information please visit: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/ 

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    USA News Group

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