ABBV AbbVie Inc.

106.78
-0.37  -0%
Previous Close 107.15
Open 107.01
52 Week Low 79.1101
52 Week High 121.53
Market Cap $188,699,003,307
Shares 1,767,175,532
Float 1,765,652,810
Enterprise Value $261,565,476,604
Volume 2,821,279
Av. Daily Volume 7,297,224
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
RINVOQ (upadacitinib)
Active Ankylosing Spondylitis
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
RINVOQ (Upadacitinib)
Psoriatic arthritis
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
RINVOQ (Upadacitinib)
Atopic Dermatitis
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Atogepant
Chronic migraine
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
RINVOQ (upadacitinib)
Crohn's disease (induction/maintenance)
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
VENCLEXTA (venetoclax) - CANOVA
Relapsed or refractory multiple myeloma
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
IMBRUVICA (Ibrutinib) + VENCLEXTA - Venetoclax (GLOW)
Chronic Lymphocytic Leukemia
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
IMBRUVICA (Ibrutinib) - (SHINE)
Mantle Cell Lymphoma
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Cenicriviroc (CVC)
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
ABBV-951
Parkinson's disease
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
SKYRIZI (risankizumab) - MOTIVATE
Crohn’s Disease
NDA Filing
NDA Filing
Phase 3 regulatory application submission to FDA for the treatment of patients 16 years and older with moderate to severe Crohn's disease, September 20, 2021.
RINVOQ (Upadacitinib) - U-ACHIEVE
Ulcerative colitis
NDA Filing
NDA Filing
NDA filed September 16, 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.
RINVOQ (Upadacitinib)
Ulcerative Colitis (maintenance)
Phase 3
Phase 3
Phase 3 trial met primary and all secondary endpoints - June 29, 2021.
ABICIPAR
Age-related macular degeneration (AMD)
CRL
CRL
CRL issued June 26, 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.
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.
VRAYLAR (cariprazine)
Major depressive disorder
Phase 3
Phase 3
Phase 3 data due 2021.
Pilocarpine (AGN-190584)
Presbyopia
NDA Filing
NDA Filing
NDA filing announced February 25, 2021.
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) vs COSENTYX (secukinumab)
Plaque psoriasis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 14, 2020.
SKYRIZI (risankizumab) - (KEEPSAKE2)
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 5, 2021.
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.
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.
IMBRUVICA (Ibrutinib) and prednisone
Chronic Graft Versus Host Disease
Phase 3
Phase 3
Phase 3 trial ongoing.
IMBRUVICA (Ibrutinib)
Relapsed or refractory MCL mantle cell lymphoma
Approved
Approved
Approved November 13, 2013.
VENCLEXTA (venetoclax) and GAZYVA (obinutuzumab)
Chronic Lymphocytic Leukemia
Phase 3
Phase 3
FDA approval announced May 15, 2019.
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)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 primary endpoint not met (PFS/OS).
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.
IMBRUVICA (ibrutinib)
Diffuse large B-cell lymphoma (DLBCL)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 11, 2018.
VIEKIRA PAK
HCV - genotype 1
Approved
Approved
Approved December 19, 2014.

Latest News

  1. NORTH CHICAGO, Ill., Sept. 20, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by safety and efficacy data from three Phase 3 studies – ADVANCE, MOTIVATE and FORTIFY.

    "While there have been advancements in care, many people with Crohn's disease do not achieve lasting remission," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie…

    NORTH CHICAGO, Ill., Sept. 20, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe Crohn's disease. The submission is supported by safety and efficacy data from three Phase 3 studies – ADVANCE, MOTIVATE and FORTIFY.

    "While there have been advancements in care, many people with Crohn's disease do not achieve lasting remission," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "This submission is an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often unpredictable disease."

    In the analysis plans for the U.S. submission of the ADVANCE and MOTIVATE induction studies, a significantly greater proportion of patients with Crohn's disease treated with either dose of risankizumab-rzaa IV induction therapy (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo.1,2

    In the analysis plans for the U.S. submission of the FORTIFY trial, a randomized-withdrawal maintenance trial of patients with clinical response to risankizumab-rzaa induction therapy, a significantly greater proportion of participants achieved the co-primary endpoints of endoscopic response and clinical remission with risankizumab-rzaa SC maintenance therapy at one year (52 weeks) for both assessed doses (360 mg or 180 mg), compared to those who were randomized to the withdrawal arm and received placebo SC (control group).3

    The safety profile of all tested doses of risankizumab-rzaa in moderate to severe Crohn's disease in the ADVANCE, MOTIVATE and FORTIFY studies was generally consistent with the known safety profile of risankizumab-rzaa.1-7

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

    About Crohn's Disease

    Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal (or digestive) tract, causing persistent diarrhea, abdominal pain, and rectal bleeding.9-11 It is a progressive disease, meaning it can get worse over time.10,11 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.8

    About the ADVANCE and MOTIVATE Studies12-14

    The ADVANCE and MOTIVATE studies are Phase 3, multicenter, randomized, double-blind, placebo-controlled induction studies designed to evaluate the efficacy and safety of two doses of risankizumab-rzaa, 600 mg and 1200 mg, in adults with moderate to severe Crohn's disease, compared to placebo. The ADVANCE study included a mixed population of patients who had responded inadequately or are intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy. Topline results of the studies were shared in January 2021, and additional analyses were presented at Digestive Disease Week® (DDW) Virtual Conference 2021. More information can be found on www.clinicaltrials.gov (ADVANCE: NCT03105128; MOTIVATE: NCT03104413).

    About the FORTIFY Study3,15

    The FORTIFY study is a Phase 3, multicenter, randomized, double-blind, control group, 52-week maintenance study designed to evaluate the efficacy and safety of risankizumab-rzaa 180 mg and 360 mg as maintenance therapy versus withdrawal who responded to risankizumab-rzaa induction treatment in the ADVANCE and MOTIVATE studies. Topline results were announced in June 2021. An open label extension of FORTIFY will continue to assess the long-term safety of risanzikumab-rzaa in subjects who completed participation in FORTIFY. More information can be found on www.clinicaltrials.gov (NCT03105102).

    About Risankizumab-rzaa (SKYRIZI®)

    SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.16 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.16,17 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, administered by a prefilled pen or prefilled syringe 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 psoriatic arthritis, Crohn's disease, and ulcerative colitis are ongoing.13-15, 18-21 The use of risankizumab-rzaa in Crohn's disease is not approved and its safety and efficacy have not been established by regulatory authorities.

    About Risankizumab-rzaa (SKYRIZI®) in the United States16

    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 Information

    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). 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 in Gastroenterology

    With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.

    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.

    References:

    1. AbbVie. Data on File: ABVRRTI71474.
    2. AbbVie. Data on File: ABBVRRI71526.
    3. AbbVie. Data on File: ABVRRTI722293.
    4. 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. Lancet. 2018 Aug 25;392(10148):650-661.
    5. 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.
    6. 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.
    7. Feagan, B., et al. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study. Lancet. 2017 Apr 29;389(10080):1699-1709. doi: 10.1016/S0140-6736(17)30570-6. Epub 2017 Apr 12.
    8. The Economic Cost of Crohn's Disease and Ulcerative Colitis. Access Economics Pty Limited. 2007. Available at: https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf. Accessed on August 26, 2021.
    9. Kaplan G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015 Dec;12(12):720-7. doi: 10.1038/nrgastro.2015.150.
    10. The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed on August 26, 2021.
    11. Crohn's disease. Symptoms and Causes. Mayo Clinic. 2020. Available at: https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304. Ac Accessed on August 26, 2021.
    12. D'Haens G, Panaccione R, Colombel JF, et al. Risankizumab induction therapy in patients with moderate-to-severe Crohn's disease: results from the ADVANCE and MOTIVATE phase 3 studies. Presented at Digestive Disease Week® (DDW) Virtual Conference 2021, May 21–23.
    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://www.clinicaltrials.gov/ct2/show/NCT03105128. Accessed on August 26, 2021.
    14. A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment. ClinicalTrials.gov. Available at https://www.clinicaltrials.gov/ct2/show/NCT03104413. Accessed on August 26, 2021.
    15. 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 August 26, 2021.
    16. SYRIZI (risankizumab-rzaa) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
    17. Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
    18. 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://www.clinicaltrials.gov/ct2/show/NCT03047395. Accessed on August 26, 2021.
    19. 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 August 26, 2021.
    20. 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://www.clinicaltrials.gov/ct2/show/NCT03671148. Accessed on August 26, 2021.
    21. 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. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03398148. Accessed on August 26, 2021.

     

    Cision View original content:https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-application-to-fda-for-risankizumab-rzaa-skyrizi-for-the-treatment-of-patients-16-years-and-older-with-moderate-to-severe-crohns-disease-301380440.html

    SOURCE AbbVie

    View Full Article Hide Full Article
  2. NORTH CHICAGO, Ill., Sept. 16, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis to the U.S. Food and Drug Administration (FDA), and to the European Medicines Agency (EMA) for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

    "Many people continue to struggle with symptoms associated with their ulcerative colitis, such as fatigue, bowel urgency, bloody diarrhea and abdominal…

    NORTH CHICAGO, Ill., Sept. 16, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active ulcerative colitis to the U.S. Food and Drug Administration (FDA), and to the European Medicines Agency (EMA) for the treatment of adults with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

    "Many people continue to struggle with symptoms associated with their ulcerative colitis, such as fatigue, bowel urgency, bloody diarrhea and abdominal pain," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "Upadacitinib has the potential to be an important new treatment option for people with ulcerative colitis, who want to address these challenging and disruptive symptoms. We look forward to working with regulatory authorities and hope to bring upadacitinib to people with ulcerative colitis as quickly as possible."

    The applications are supported by data from two Phase 3 induction studies and one maintenance study.1-3 In these studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and all secondary endpoints compared to placebo with 45 mg once daily at week 8 for the induction studies, and with 15 mg and 30 mg once daily at 52 weeks for the maintenance study.1-3

    The safety results of upadacitinib, including the 45 mg dose as induction therapy, in these studies were generally consistent with the known safety profile of upadacitinib, with no new important safety risks observed.1-7

    About Ulcerative Colitis

    Ulcerative colitis is a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.15,16 The hallmark signs and symptoms of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.15,17 The disease course of ulcerative colitis varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or complications, including cancer or death.16,19 The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.18

    About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies1-3,14-16

    The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of upadacitinib 45 mg once daily as induction therapy, and upadacitinib 15 mg and 30 mg once daily as maintenance therapy in subjects with moderate to severe ulcerative colitis. Topline results of the U-ACHIEVE induction study were announced in December 2020, topline results of the second induction study, U-ACCOMPLISH, were announced in February 2021, and topline results of the U-ACHIEVE maintenance study were announced in June 2021. More information can be found on www.clinicaltrials.gov (NCT03006068, NCT03653026, NCT02819635).

    About Upadacitinib (RINVOQ®)

    Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-3,14-22 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.30 RINVOQ 15 mg is approved in the U.S. for adults with moderately to severely active rheumatoid arthritis. RINVOQ 15 mg also is approved in the EU for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), adults with active ankylosing spondylitis (AS), and adults and adolescents 12 years and older with moderate to severe atopic dermatitis (AD). RINVOQ 30 mg is approved in the EU for adults with moderate to severe AD under age 65. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondylarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.21-29 Use of RINVOQ in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

    Important Safety Information about RINVOQ (upadacitinib) in the United States

    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.

    Please see the Full Prescribing Information, including the Medication Guide, for RINVOQ. 

    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 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.

    Important EU Safety Information about RINVOQ® (upadacitinib)30

    Rheumatoid arthritis

    RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.

    Psoriatic arthritis

    RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.

    Ankylosing spondylitis

    RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

    Atopic dermatitis

    RINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

    Contraindications

    RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.

    Special warnings and precautions for use

    Immunosuppressive medicinal products

    Use in combination with other potent immunosuppressants is not recommended.

    Serious infections

    Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported with upadacitinib. As there is a higher incidence of infections in patients ≥65 years of age, caution should be used when treating this population.

    Viral reactivation

    Viral reactivation, including cases of herpes zoster, was reported in clinical studies. The risk of herpes zoster appears to be higher in Japanese patients treated with upadacitinib.

    Vaccinations

    The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines. 

    Malignancy

    The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Malignancies, including nonmelanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy.

    Hematological abnormalities

    Treatment should not be initiated, or should be temporarily interrupted, in patients with hematological abnormalities observed during routine patient management.

    Cardiovascular risk

    RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidemia) managed as part of usual standard of care.

    Lipids

    Upadacitinib treatment was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.

    Hepatic transaminase elevations

    Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.

    Venous thromboembolisms

    Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE.

    Adverse reactions

    The most commonly reported adverse reactions in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis clinical trials (≥2% of patients in at least one of the indications) with upadacitinib 15 mg were upper respiratory tract infections, blood creatine phosphokinase (CPK) increased, alanine transaminase increased, bronchitis, nausea, cough, aspartate transaminase increased, and hypercholesterolemia.

    The most commonly reported adverse reactions in atopic dermatitis trials (≥2% of patients) with upadacitinib 15 mg or 30 mg were upper respiratory tract infection, acne, herpes simplex, headache, CPK increased, cough, folliculitis, abdominal pain, nausea, neutropenia, pyrexia, and influenza.

    Ankylosing spondylitis:

    Overall, the safety profile observed in patients with active ankylosing spondylitis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with RA.

    Psoriatic arthritis:

    Overall, the safety profile observed in patients with active psoriatic arthritis treated with upadacitinib 15 mg was consistent with the safety profile observed in patients with RA. A higher incidence of acne and bronchitis was observed in patients treated with upadacitinib 15 mg (1.3% and 3.9%, respectively) compared to placebo (0.3% and 2.7%, respectively). A higher rate of serious infections (2.6 events per 100 patient-years and 1.3 events per 100 patient-years, respectively) and hepatic transaminase elevations (ALT elevations Grade 3 and higher rates 1.4% and 0.4%, respectively) was observed in patients treated with upadacitinib in combination with MTX therapy compared to patients treated with monotherapy. There was a higher rate of serious infections in patients ≥65 years of age, although data are limited.

    Atopic dermatitis:

    Dose-dependent changes in ALT increased and/or AST increased (≥ 3 x ULN), lipid parameters, CPK values (> 5 x ULN), and neutropenia (ANC < 1 x 109 cells/L) associated with upadacitinib treatment were similar to what was observed in the rheumatologic disease clinical studies. Based on limited data in atopic dermatitis patients aged 65 years and older, there was a higher rate of overall adverse reactions with the upadacitinib 30 mg dose compared to the 15 mg dose. The safety profile for upadacitinib 15 mg in adolescents was similar to that in adults. The safety and efficacy of the 30 mg dose in adolescents are still being investigated.

    This is not a complete summary of all safety information.

    Please see the full SmPC for complete prescribing information at www.EMA.europa.eu. 

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

    About AbbVie in Gastroenterology

    With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. For more information on AbbVie in gastroenterology, visit https://www.abbvie.com/our-science/therapeutic-focus-areas/immunology/immunology-focus-areas/gastroenterology.html.

    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, FacebookLinkedIn 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. AbbVie. Data on File: ABVRRTI71469.
    2. AbbVie. Data on File: ABVRRTI71710.
    3. AbbVie. Data on File: ABVRRTI72381.
    4. Cohen S., et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.
    5. Mease P.J., et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2020 Dec 3;annrheumdis-2020-218870. doi: 10.1136/annrheumdis-2020-218870.
    6. Van der Heijde D., et al. Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study of Patients With Active Ankylosing Spondylitis. 2019 ACR/ARP Annual Meeting; 2728.
    7. Guttman-Yassky, E., et al. Safety and Efficacy of Upadacitinib Monotherapy in Adolescents and Adults with Moderate-to-severe Atopic Dermatitis: Results From 2 Pivotal, Phase 3, Randomized, Double-blinded, Monotherapy, Placebo-controlled Studies (Measure Up 1 and Measure Up 2). European Academy of Dermatology and Venerology Congress. 2020. D3T03.4B.
    8. 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.
    9. Blauvelt A., et al. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. Published online August 4, 2021. doi:10.1001/jamadermatol.2021.3023.
    10. EPAR: RINVOQ [European Public Assessment Report]. AbbVie Deutschland GmbH & Co. KG. December 2019. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/rinvoq.
    11. Reich K., 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.
    12. Rubbert-Roth A., et al. Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. N Engl J Med. 2020;383(16):1511-1521. doi:10.1056/NEJMoa2008250.
    13. Kameda H., et al. Efficacy and safety of upadacitinib in Japanese patients with rheumatoid arthritis (SELECT-SUNRISE): a placebo-controlled phase llb/lll study. Rheumatology (Oxford). 2020;59(11):3303-3313. doi:10.1093/rheumatology/keaa084 .
    14. A Study to Evaluate Safety of Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis (Rising Up). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03661138. Accessed on August 19, 2021.
    15. Gajendran M., et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019 Dec;65(12):100851. doi: 10.1016/j.disamonth.2019.02.004. Epub 2019 Mar 2.
    16. The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed on August 20, 2021.
    17. Ulcerative colitis. Symptoms and Causes. Mayo Clinic. 2020. Available at: https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326. Accessed on August 20, 2021.
    18. Mehta F. Report: economic implications of inflammatory bowel disease and its management. Am J Manag Care. 2016 Mar;22(3 Suppl):s51-60.
    19. Monstad, I., et al. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol. 2014; 27(2): 95–104.
    20. RINVOQ® (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
    21. A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03006068. Accessed on August 20, 2021.
    22. A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-Accomplish). ClinicalTrials.gov 2021. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03653026. Accessed on August 20, 2021.
    23. 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://www.clinicaltrials.gov/ct2/show/NCT02819635. Accessed on August 20, 2021
    24. Pipeline – Our Science | AbbVie. AbbVie. 2019. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on August 20, 2021.
    25. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on August 20, 2021.
    26. 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 August 20, 2021.
    27. 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. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on Accessed on August 20, 2021.
    28. 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 August 20, 2021.
    29. 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 August 20, 2021.
    30. RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.

     

    Cision View original content:https://www.prnewswire.com/news-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-upadacitinib-rinvoq-for-the-treatment-of-adults-with-moderately-to-severely-active-ulcerative-colitis-301378586.html

    SOURCE AbbVie

    View Full Article Hide Full Article
  3. NORTH CHICAGO, Ill. and ROCKVILLE, Md., Sept. 13, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) and REGENXBIO Inc. (NASDAQ:RGNX) today announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery. 

    Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on…

    NORTH CHICAGO, Ill. and ROCKVILLE, Md., Sept. 13, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) and REGENXBIO Inc. (NASDAQ:RGNX) today announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery. 

    Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO shall participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan.

    "We are committed to finding solutions for patients living with difficult-to-treat retinal diseases and to helping preserve and protect our patients from visual impairment and devastating vision loss," said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. "In collaboration with REGENXBIO, we aim to make a remarkable impact for the millions of patients suffering from vision loss associated with retinal diseases."

    "AbbVie is a strong, complementary partner for REGENXBIO. We expect to leverage AbbVie's global developmental and commercial infrastructure within eye care with our expertise in AAV gene therapy clinical development and deep in-house knowledge of manufacturing and production to continue the development of RGX-314," said Kenneth T. Mills, president and chief executive officer of REGENXBIO.

    Under the terms of the agreement, AbbVie will pay REGENXBIO a $370 million upfront payment with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones. REGENXBIO and AbbVie will share equally in profits from net sales of RGX-314 in the U.S. AbbVie will pay REGENXBIO tiered royalties on net sales of RGX-314 outside the U.S. In addition, REGENXBIO will lead the manufacturing of RGX-314 for clinical development and U.S. commercial supply, and AbbVie will lead manufacturing of RGX-314 for commercial supply outside the U.S.  

    The transaction is expected to close by the end of 2021, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.

    REGENXBIO Conference Call

    In connection with this announcement, REGENXBIO will host a webcast and conference call today at 8:00 a.m. ET. To access a live or recorded webcast of the call, please visit the "Investors" section of the REGENXBIO website at www.regenxbio.com. To access the live call by phone, dial (855) 422-8964 (domestic) or (210) 229-8819 (international) and enter the passcode 6379638. The recorded webcast will be available for approximately 30 days following the call.

    About RGX-314

    RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina1.

    REGENXBIO is advancing research in two separate routes of administration of RGX-314 to the eye, through a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. REGENXBIO has licensed certain exclusive rights to the SCS Microinjector® from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye.

    About Wet AMD

    Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina2. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone3. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients4. These therapies, however, require life-long repeated intraocular injections, to maintain efficacy5,6.  Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time7.

    About Diabetic Retinopathy

    Diabetic retinopathy (DR) is the leading cause of vision loss in adults between 24 and 75 years of age worldwide8. DR affects approximately eight million people in the United States alone9. The spectrum of DR severity ranges from non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) and as DR progresses, a large proportion of patients develop vision threatening complications, including diabetic macular edema (DME) and neovascularization that can lead to blindness10.  Current treatment options for patients with DR include "watchful waiting", anti-VEGF treatment, retinal laser or surgical treatment8.

    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.

    About REGENXBIO Inc.

    REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

    AbbVie 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.

    REGENXBIO Forward-Looking Statements

    This press release includes "forward-looking statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate," "continue," "anticipate," "assume," "design," "intend," "expect," "could," "plan," "potential," "predict," "seek," "should," "would" or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO's proposed collaboration with AbbVie and REGENXBIO's future operations and clinical trials. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties, including the anticipated completion of REGENXBIO's proposed transaction with AbbVie, the outcome of REGENXBIO's proposed collaboration with AbbVie and other factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the year ended December 31, 2020 and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC's website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    References

    1.

    Penn JS, Madan A, Caldwell RB, et al. Vascular endothelial growth factor in eye disease. Prog Retin Eye Res. 2008;27(4):331-71.

    2.

    Carmeliet P. Angiogenesis in life, disease and medicine. Nature. 2005;438:932-6.

    3.

    Decision Resources Group, 2019

    4.

    Alexandru MR, Alexandra NM. Wet age related macular degeneration management and follow-up. Rom J Ophthalmol. 2016;60:9–13.

    5.

    AAO PPP. Preferred Practice Patterns: Age related macular degeneration. American Academy of Ophthalmology. 2019.

    6.

    Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.

    7.

    Holz FG et al. Br J Ophthalmol. 2015;99:220.

    8.

    Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010;376(9735):124–36.

    9.

    Wittenborn, J.S. and D.B. Rein. Cost of Vision Problems: The future of vision, forecasting the prevalence and costs of vision problems. 2014. NORC at the University of Chicago: Chicago

    10.

    Berrocal MD, Alexandra Acabá. Current Management of Diabetic Retinopathy, 2018

     

    Cision View original content:https://www.prnewswire.com/news-releases/abbvie-and-regenxbio-announce-eye-care-collaboration-301374836.html

    SOURCE AbbVie; REGENXBIO

    View Full Article Hide Full Article
  4. NORTH CHICAGO, Ill., Sept. 10, 2021 /PRNewswire/ -- The board of directors of AbbVie Inc. (NYSE:ABBV) today declared a quarterly cash dividend of $1.30 per share. 

    The cash dividend is payable November 15, 2021 to stockholders of record at the close of business on October 15, 2021.

    Since the company's inception in 2013, AbbVie has increased its dividend by 225 percent.  AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

    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…

    NORTH CHICAGO, Ill., Sept. 10, 2021 /PRNewswire/ -- The board of directors of AbbVie Inc. (NYSE:ABBV) today declared a quarterly cash dividend of $1.30 per share. 

    The cash dividend is payable November 15, 2021 to stockholders of record at the close of business on October 15, 2021.

    Since the company's inception in 2013, AbbVie has increased its dividend by 225 percent.  AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

    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-declares-quarterly-dividend-301373397.html

    SOURCE AbbVie

    View Full Article Hide Full Article
  5. NORTH CHICAGO, Ill., Sept. 10, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that data from its robust neuroscience portfolio will be presented at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021, taking place September 17-22. More than 20 abstracts across disease states, including Parkinson's disease, spasticity and cervical dystonia, will be presented.

    "At AbbVie, we are committed to addressing the unmet needs of people living with a wide range of movement disorders," said Sebastian Sorsaburu, MD, vice president, global specialty care medical affairs, AbbVie. "Our research presented at MDS 2021 builds upon our expertise in neuroscience and reinforces our mission to advance the standards of care…

    NORTH CHICAGO, Ill., Sept. 10, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that data from its robust neuroscience portfolio will be presented at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021, taking place September 17-22. More than 20 abstracts across disease states, including Parkinson's disease, spasticity and cervical dystonia, will be presented.

    "At AbbVie, we are committed to addressing the unmet needs of people living with a wide range of movement disorders," said Sebastian Sorsaburu, MD, vice president, global specialty care medical affairs, AbbVie. "Our research presented at MDS 2021 builds upon our expertise in neuroscience and reinforces our mission to advance the standards of care for people living with these debilitating diseases."

    Researchers will present results from several studies in advanced Parkinson's disease, including long-term, real-world data for DUODOPA® (levodopa-carbidopa intestinal gel), as well as additional data on the long-term, real-world use of BOTOX® (onabotulinumtoxinA) in patients with spasticity and cervical dystonia.

    Key AbbVie abstracts for the MDS Virtual Congress 2021, which will all be available as virtual e-posters beginning at 8:00 a.m. CDT on September 10, are outlined below.

    Key AbbVie Abstracts at MDS 2021

    Abstract Title

    DUODOPA® Abstracts

    Dyskinesia, Pain, and Quality of Life in Parkinson's Disease: Post Hoc Analysis from the DYSCOVER Study

    Effects of Levodopa-Carbidopa Intestinal Gel on Dyskinesia and Non-Motor Symptoms Including Sleep: Results from a Meta-Analysis with 24-Month Follow-Up

    Registry Analysis (In Progress) to Evaluate Clinical Outcomes and Disease Burden of Advanced PD in Patients with Motor Fluctuations and Dyskinesia Managed with Oral Dopaminergic Therapies Versus Device-Aided Therapies

    Impact on Dyskinesia in Advanced Parkinson's Disease Patients Treated with LCIG: Analysis from the COSMOS Study

    Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Patients with Advanced Parkinson's Disease

    Long-Term Real-World Effectiveness of Carbidopa/Levodopa Enteral Suspension After 36 Months of Treatment Initiation: Final Results from PROviDE Study

    Levodopa/Carbidopa Intestinal Gel (LCIG) Reduces Fluctuations and Shortens Time to On Without Troublesome Dyskinesia in Advanced Parkinson's Disease: Post-Hoc Analyses of 54-week LCIG-Monotherapy Trial

    Real-World Characteristics of Advanced Parkinson's Disease Patients Initiating Carbidopa/Levodopa Enteral Suspension

    Impact of Device-Aided Therapies on QoL and Off-Time Improvement in Advanced Parkinson's Disease Patients: Comparative Effectiveness Results from a Bayesian Network Meta-Analysis

    Overview of the Population of Patients with Advanced Parkinson's Disease (aPD) Initiating Therapy with Levodopa-Carbidopa Intestinal Gel (LCIG): POMPE-PARK Study on French Health Insurance Data (2013-2017)

    BOTOX® Abstracts

    OnabotulinumtoxinA Treatment in Patients with Upper Limb and Lower Limb Spasticity from the ASPIRE Study

    Neutralizing Antibody Conversion with OnabotulinumtoxinA from Global Studies Across Multiple Indications with a Focus on Movement Disorders: A Meta-Analysis

    Benefits of Treatment with OnabotulinumtoxinA in Naive and Non-Naive Patients with Cervical Dystonia are Sustained Over Time: Preliminary Completer Analysis from CD PROBE

    Impact of Disease Severity on Presentation Subtype and OnabotulinumtoxinA Utilization in Patients with Cervical Dystonia: Results from the CD PROBE Completer Population

    A Cell-Penetrating Peptide (CPP) Did Not Decrease 150-kDa BoNT/A Toxin Adsorption to Surfaces or Increase Toxin Potency or Duration in a Prototype Formulation

    OnabotulinumtoxinA Exhibits Greater Efficacy Compared to Purified Botulinum Neurotoxin A (Bont/A-150 KDA) in Peripheral Pain Models

    Disease State Abstracts

    Classification of Advanced Parkinson's Disease in OBSERVE-PD Patients Based on the MANAGE-PD Screening Tool

    COVID-19 Pandemic Impact on Advanced Parkinson's Disease in the US

    Current Perspectives on the Management of Cervical Dystonia Among Global Clinicians

    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.

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

    DUODOPA® (levodopa/carbidopa intestinal gel) EU Indication

    DUODOPA® is indicated for the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson's medicinal products have not given satisfactory results.

    Important DUODOPA® EU Safety Information

    Duodopa is contraindicated in patients with hypersensitivity to levodopa, carbidopa or any of the excipients, narrow-angle glaucoma, severe heart failure, severe cardiac arrhythmia, acute stroke, selective type A inhibitors and nonselective MAO inhibitors, conditions contraindicated for adrenergics (e.g. pheochromocytoma, hyperthyroidism, and Cushing's syndrome), and suspicious skin lesions or history of melanoma.

    Some warnings and precautions include the following: Device and Procedure-related complications, sudden onset of sleep: caution should be exercised when driving and operating machines. Caution in: severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease or of convulsions. Risk of symptoms resembling Neuroleptic Malignant Syndrome following abrupt dose reduction or discontinuation. Monitor all patients for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Caution in chronic wide-angle glaucoma; monitor for intra-ocular pressure changes. Patients with past or current psychosis should be treated with caution. Monitor patients regularly for the development of impulse control disorders, for example Dopamine Dysregulation Syndrome (DDS). Polyneuropathy has been reported; evaluate for history/signs of and known risk factors before starting therapy. Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Duodopa. Some reported complications include, but are not limited to, abscess, pneumonia (including aspiration pneumonia), and sepsis. Patients with Parkinson's disease have a higher risk of developing melanoma. Monitor patients for melanomas on a regular basis when using Duodopa. Duodopa is not recommended during pregnancy. Breast-feeding should be discontinued during treatment with Duodopa.

    The most common adverse reaction was complication of device insertion.

    The very common (≥ 10%) and common  (≥1% to < 10%) device and procedure -related adverse reactions reported in the clinical trials included in clinical trials included: Abdominal discomfort, Abdominal pain, Peritonitis, Pneumoperitoneum Postoperative wound infection, incisional cellulitis, pneumonia/aspiration pneumonia, excessive granulation tissue, device dislocation, device occlusion, complications of device insertion, incision site erythema, post-procedural discharge, stoma complication, incision site pain, Postoperative Ileus, Post procedural complication, Post procedural discomfort, post procedural haemorrhage.

    Most of these adverse reactions were reported early in the studies, subsequent to the percutaneous endoscopic gastrostomy procedure and occurred during the first 28 days.

    Drug related undesirable effects that occur frequently with the Duodopa system include nausea and dyskinesia.

    This is not a complete summary of all safety information.

    See DUODOPA® full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc/. Globally, prescribing information varies; refer to the individual country product label for complete information.

    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:https://www.prnewswire.com/news-releases/abbvie-to-highlight-its-leadership-in-movement-disorders-at-the-international-parkinson-and-movement-disorder-society-virtual-congress-2021-301373043.html

    SOURCE AbbVie

    View Full Article Hide Full Article
View All AbbVie Inc. News