ABBV AbbVie Inc.

82.71
-1.21  -1%
Previous Close 83.92
Open 84
52 Week Low 62.55
52 Week High 101.28
Market Cap $145,969,357,777
Shares 1,764,833,246
Float 1,763,480,422
Enterprise Value $230,238,035,967
Volume 6,690,118
Av. Daily Volume 7,143,809
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Imbruvica + Venclexta (CAPTIVATE)
Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Phase 2
Phase 2
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.
Risankizumab KEEPSAKE2
Psoriatic Arthritis
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
RELAMORELIN
Diabetic Gastroparesis
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Risankizumab MOTIVATE
Crohn’s Disease
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Risankizumab vs secukinumab
Psoriasis
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Ibrutinib in combination with prednisone
Chronic Graft Versus Host Disease
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Botox
Neurogenic Detrusor Overactivity
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Upadacitinib
Psoriatic arthritis
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
RINVOQ (upadacitinib)
Active Ankylosing Spondylitis
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Venetoclax - CANOVA
Relapsed or refractory multiple myeloma
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.
Cenicriviroc (CVC)
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

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

Latest News

  1. NORTH CHICAGO, Ill., Oct. 19, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ™ (upadacitinib) for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis.

    The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal Phase 3 studies. RINVOQ was studied without topical corticosteroids (TCS) in Measure Up 1 and Measure Up 2 and with TCS in AD Up.1-3 In all three studies, RINVOQ demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents…

    NORTH CHICAGO, Ill., Oct. 19, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ™ (upadacitinib) for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis.

    The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal Phase 3 studies. RINVOQ was studied without topical corticosteroids (TCS) in Measure Up 1 and Measure Up 2 and with TCS in AD Up.1-3 In all three studies, RINVOQ demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe atopic dermatitis compared to placebo.1-3 RINVOQ met the co-primary endpoints including at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.1-3 Additionally, more patients treated with either dose of upadacitinib experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS)≥4.1-3 The safety profile of RINVOQ was consistent across the three pivotal Phase 3 studies in atopic dermatitis.1-3 No new safety risks of RINVOQ were observed in these studies compared to the safety profile observed in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis receiving RINVOQ.1-3,8-11

    "While there have been advancements in care, patients with moderate to severe atopic dermatitis continue to experience relentless itch and skin symptoms that can impact their everyday lives," said Michael Severino, M.D., vice chairman and president, AbbVie. "These submissions are an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often underappreciated disease."

    Atopic dermatitis is characterized by a cycle of itching and scratching that leads to cracked, scaly, oozing skin, which intensifies with worsening disease severity.4,5,12 Between 20 to 46 percent of adults with atopic dermatitis have moderate to severe disease.13 The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.4-6

    About RINVOQ™ (upadacitinib)

    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 August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis, psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.14-22 Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy have not been established by regulatory authorities.

    Important Safety Information about RINVOQ™ (upadacitinib)23

    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
      • Pain or tenderness in the leg
      • Sudden unexplained chest pain
      • Shortness of breath
    • Have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

    What are the common side effects of RINVOQ?

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

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

    This is the most important information to know about RINVOQ. For more information, talk to your HCP.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit 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 TwitterFacebookInstagramYouTube 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 2019 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. ABVRRTI70713.
    2. AbbVie Data on File. ABVRRTI70838.
    3. AbbVie Data on File. ABVRRTI70869.
    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. EFA. Atopic Eczema: Itching for Life Report. 2018. Available at: https://www.efanet.org/images/2018/EN_-_Itching_for_life_Quality_of_Life_and_costs_for_people_with_severe_atopic_eczema_in_Europe_.pdf. Accessed on October 13, 2020.
    7. Eichenfield LF, 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.
    8. Cohen S., et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.
    9. Genovese MC, et al. Efficacy and Safety of Upadacitinib in Patients With Active Psoriatic Arthritis and Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA-2): a Double-Blind, Randomized Controlled Phase 3 Trial. 2020 EULAR E-Congress; OP0223.
    10. McInnes I, et al. Efficacy and Safety of Upadacitinib Versus Placebo and Adalimumab in Patients With Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA-1): a Double-Blind, Randomized Controlled Phase 3 Trial. 2020 EULAR E-Congress; LB0001.
    11. 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; 2728.
    12. University of Michigan Medicine. Atopic Dermatitis (Eczema). 2020. Available at: https://www.uofmhealth.org/health-library/hw216104#hw216107. Accessed on October 13, 2020.
    13. Shrestha S, et al. Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal Databases. Adv Ther. 2017;34(8):1989–2006.
    14. Pipeline – Our Science | AbbVie. AbbVie. 2020. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on October 13, 2020.
    15. Burmester GR, et al. Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
    16. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on October 13, 2020.
    17. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on October 13, 2020.
    18. A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on October 13, 2020.
    19. A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on October 13, 2020.
    20. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on October 13, 2020.
    21. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on October 13, 2020.
    22. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed on October 13, 2020.
    23. RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

     

    Cision View original content:http://www.prnewswire.com/news-releases/abbvie-submits-regulatory-applications-to-fda-and-ema-for-rinvoq-upadacitinib-in-atopic-dermatitis-301154849.html

    SOURCE AbbVie

    View Full Article Hide Full Article
  2. NORTH CHICAGO, Ill., Oct. 19, 2020 /PRNewswire/ -- ("AbbVie") announced today the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $30,000,000,000 aggregate principal amount of senior unsecured notes previously issued on November 21, 2019 (the "2019 USD Notes"), (ii) $13,251,781,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "2020 USD Notes" and, together with the 2019 USD Notes, the "USD Notes") and (iii) €2,517,066,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "Euro Notes" and, together with the USD Notes, the "Original Notes"), each issued pursuant to an exemption from the registration…

    NORTH CHICAGO, Ill., Oct. 19, 2020 /PRNewswire/ -- ("AbbVie") announced today the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $30,000,000,000 aggregate principal amount of senior unsecured notes previously issued on November 21, 2019 (the "2019 USD Notes"), (ii) $13,251,781,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "2020 USD Notes" and, together with the 2019 USD Notes, the "USD Notes") and (iii) €2,517,066,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "Euro Notes" and, together with the USD Notes, the "Original Notes"), each issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes").

    The 2019 USD Notes were issued in a private offering to fund a portion of the aggregate cash consideration payable in connection with AbbVie's acquisition of Allergan plc ("Allergan") and to pay related fees and expenses. The 2020 USD Notes and the Euro Notes were issued in a private offering upon the completion of AbbVie's offers to exchange (the "prior exchange offers") any and all outstanding notes issued by certain of Allergan's subsidiaries. 

    AbbVie is offering to issue the Registered Notes to satisfy its obligations under the registration rights agreement entered into with the initial purchasers of the 2019 USD Notes and the registration rights agreement entered into with the dealer managers for the prior exchange offers. The Registered Exchange Offers do not represent a new financing transaction.

    The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the offering of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. AbbVie will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes.

    The following table sets forth the outstanding aggregate principal amount of each series of Original Notes. The Registered Exchange Offers consist of offers to exchange up to the entire aggregate principal amount of each series of Original Notes for an equal principal amount of the corresponding series of Registered Notes.

    Title of Series of Original Notes

    Amount

    Outstanding

    Senior Floating Rate Notes due May 2021

    $750,000,000

    Senior Floating Rate Notes due November 2021

    $750,000,000

    2.150% Senior Notes due 2021

    $1,750,000,000

    5.000% Senior Notes due 2021

    $1,175,701,000

    3.450% Senior Notes due 2022

    $2,627,036,000

    3.250% Senior Notes due 2022

    $1,462,358,000

    Senior Floating Rate Notes due 2022

    $750,000,000

    2.300% Senior Notes due 2022

    $3,000,000,000

    2.800% Senior Notes due 2023

    $244,575,000

    3.850% Senior Notes due 2024

    $945,394,000

    2.600% Senior Notes due 2024

    $3,750,000,000

    3.800% Senior Notes due 2025

    $2,890,467,000

    2.950% Senior Notes due 2026

    $4,000,000,000

    3.200% Senior Notes due 2029

    $5,500,000,000

    4.550% Senior Notes due 2035

    $1,681,354,000

    4.050% Senior Notes due 2039

    $4,000,000,000

    4.625% Senior Notes due 2042

    $389,217,000

    4.850% Senior Notes due 2044

    $1,008,583,000

    4.750% Senior Notes due 2045

    $827,096,000

    4.250% Senior Notes due 2049

    $5,750,000,000

    0.500% Senior Notes due 2021

    €539,018,000

    1.500% Senior Notes due 2023

    €433,228,000

    1.250% Senior Notes due 2024

    €603,389,000

    2.625% Senior Notes due 2028

    €427,893,000

    2.125% Senior Notes due 2029

    €513,538,000

    AbbVie will accept for exchange any and all Original Notes validly tendered and not validly withdrawn prior to 5:00 p.m., New York City time, on November 17, 2020 (as the same may be extended by AbbVie with respect to one or more series of Original Notes, the "Expiration Date"). Prior to the Expiration Date, tenders of Original Notes may be withdrawn according to the procedures described in the Prospectus (as defined below). Promptly after the Expiration Date, AbbVie will settle the Registered Exchange Offers by issuing Registered Notes pursuant to the terms of the Registered Exchange Offers.

    A Registration Statement on Form S-4 (File No. 333-249277) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on October 2, 2020 and was declared effective on October 16, 2020. The Registered Exchange Offers are being made pursuant to the terms and subject to the conditions set forth in a prospectus dated October 19, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement. The complete terms and conditions of the Registered Exchange Offers, including instructions regarding procedures for tendering Original Notes, are described in the Prospectus, the Registration Statement and related letter of transmittal, copies of which may be obtained by contacting (i) U.S Bank National Association, the exchange agent in connection with the Registered Exchange Offers for the USD Notes, at (800) 934-6802 or (ii) Elavon Financial Services DAC, the exchange agent in connection with the Registered Exchange Offers for the Euro Notes, at +44 (0) 207 330 2000.

    This press release is not an offer to sell or exchange or a solicitation of an offer to buy or exchange any of the securities described herein. The Registered Exchange Offers are being made solely pursuant to the terms and conditions of the Prospectus, the Registration Statement, the related letter of transmittal and the other related materials.

    About AbbVie

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

    Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn.

    Cautionary Statement Regarding Forward-Looking Statements

    Some statements in this press release may be 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, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results, which 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 (the "Acquisition"), the failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Acquisition, 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. These forward-looking statements are based on numerous assumptions and assessments made in light of AbbVie's experience and perception of historical trends, current conditions, business strategies, operating environment, future developments and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The factors described in the context of such forward-looking statements in this press release could cause AbbVie's plans with respect to Allergan or AbbVie's actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements. Although it is believed that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this press release herein are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as at the date of this press release. Additional information about economic, competitive, governmental, technological and other factors that may affect AbbVie is set forth in the Prospectus under "Risk Factors" and in AbbVie's filings with the Securities and Exchange Commission, including the risk factors discussed in AbbVie's most recent Annual Report on Form 10-K, 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 notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995.

    Any forward-looking statements in this press release are based upon information available to AbbVie as of the date of this press release and, while believed to be true when made, may ultimately prove to be incorrect. Subject to any obligations under applicable law, AbbVie undertakes no obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. All subsequent written and oral forward-looking statements attributable to AbbVie or any person acting on its behalf are expressly qualified in their entirety by this paragraph.

    Please carefully review and consider the various disclosures made in this press release, the Prospectus and the documents incorporated by reference therein that attempt to advise interested parties of the risks and factors that may affect our business, prospects and results of operations

    Cision View original content:http://www.prnewswire.com/news-releases/abbvie-announces-commencement-of-registered-exchange-offers-301154775.html

    SOURCE AbbVie

    View Full Article Hide Full Article
  3. NORTH CHICAGO, Ill., Oct. 16, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. The approval is supported by data from the Phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies and updated data from the Phase 1b M14-358 and the Phase 1/2 M14-387 studies. The FDA previously granted accelerated approval to VENCLEXTA for this indication in 2018.5

    "AML is a complex and challenging…

    NORTH CHICAGO, Ill., Oct. 16, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced that the U.S. Food and Drug Administration (FDA) has provided full approval to VENCLEXTA® (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. The approval is supported by data from the Phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies and updated data from the Phase 1b M14-358 and the Phase 1/2 M14-387 studies. The FDA previously granted accelerated approval to VENCLEXTA for this indication in 2018.5

    "AML is a complex and challenging disease with generally low survival rates. This approval is significant because data from our VIALE-A trial has shown that newly-diagnosed patients, who cannot undergo intensive chemotherapy, lived longer when treated with VENCLEXTA plus azacitidine than those treated with azacitidine alone," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology development, AbbVie. "This trial also provides physicians more information for managing patients - from treatment initiation, to assessing response and management post disease remission."

    Positive overall survival (OS) data seen at an interim analysis of the VIALE-A trial led to an early submission supporting the FDA approval of VENCLEXTA in AML. The trial showed patients on the active regimen of VENCLEXTA plus azacitidine achieved a 34% reduction in the risk of death compared to azacitidine in combination with placebo (Hazard Ratio [HR]=0.66 [95% CI: 0.52-0.85], p<0.001). The median OS for patients in the VENCLEXTA arm was 14.7 months (95% CI: 11.9, 18.7) versus 9.6 months in the placebo arm (95% CI: 7.4, 12.7). Additionally, patients in the VENCLEXTA plus azacitidine arm achieved a complete remission (CR) rate of 37% (95% CI: 31%, 43%) with a median duration of CR of 18.0 months (95% CI: 15.3, -) compared with patients in the placebo plus azacitidine arm with a CR rate of 18% (95% CI: 12%, 25%) with a median duration of CR of 13.4 months (95% CI: 8.7, 17.6). The observed safety profile was generally consistent with the known safety profile of VENCLEXTA in combination with azacitidine. For patients taking VENCLEXTA in combination with azacitidine, the most frequent serious adverse reactions (ARs; ≥5%) at first use were febrile neutropenia (30%), pneumonia (22%), sepsis (excluding fungal; 19%) and hemorrhage (6%).1,6

    Data from VIALE-A was presented for the first time as a late-breaking abstract at the 25th European Hematology Association (EHA) Annual Congress in June 2020 and recently published in the New England Journal of Medicine.7

    "For far too long, people with AML had very few treatment options, aside from very intense chemotherapy. Today's news continues the progress of bringing more treatment options to patients with this devastating disease," said Lee Greenberger, Ph.D., chief scientific officer of The Leukemia & Lymphoma Society.

    Data from the VIALE-C trial was presented at both the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting and the EHA Annual Congress and previously published in Blood.8 The median OS for VENCLEXTA in combination with LDAC was 7.2 months (95% CI: 5.6, 10.1) and 4.1 months for LDAC in combination with placebo (95% CI: 3.1, 8.8). The HR for the primary endpoint of OS was 0.75 (95% CI: 0.52-1.07; p=0.114). The trial did not meet its primary endpoint of statistically significant improvement of OS for patients with AML who are ineligible for intensive chemotherapy at the time of the planned analysis. Efficacy was based on the rate of CR and duration of CR with supportive evidence of rate of CR + complete remission with partial hematologic recovery (CR+CRh), duration of CR+CRh, and the rate of conversion from transfusion dependence to transfusion independence. In the VENCLEXTA arm, the most frequent serious ARs were (≥10%) pneumonia (17%), febrile neutropenia (16%) and sepsis (excluding fungal; 12%).1,9

    AML is an aggressive and difficult-to-treat blood cancer with a low survival rate.2,3 Despite recent advances in available therapies, the five-year survival rate for patients diagnosed with AML remains approximately 29%.10 AML typically worsens quickly, and due to age or comorbidities, not all patients are eligible to receive intensive chemotherapy.11 

    The FDA reviewed the clinical data under the FDA's Real-Time Oncology Review (RTOR) pilot program and Project Orbis initiative, which led to approval in the U.S. in October 2020. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The U.S. FDA, the Australian Therapeutic Goods Administration, Swissmedic, Health Canada and ANVISA (Agência Nacional de Vigilância Sanitária) collaborated on this review based on the marketing applications submitted in their respective countries.

    Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

    About the VIALE-A and VIALE-C Clinical Trials

    VIALE-A (M15-656) Phase 3 Trial1,7 

    A total of 431 patients were randomized in the double-blind, placebo-controlled, multicenter, Phase 3 VIALE-A trial, which evaluated the efficacy and safety of VENCLEXTA in combination with azacitidine (n=286) in patients with AML who are ineligible for standard induction therapy versus azacitidine in combination with placebo (n=145). The primary endpoint was OS.

    The VENCLEXTA plus azacitidine combination showed a median OS of 14.7 months (95% CI: 11.9, 18.7) versus 9.6 months (95% CI: 7.4, 12.7) with azacitidine in combination with placebo. The study also met its secondary endpoints, with the VENCLEXTA combination arm resulting in a CR rate of 37% (95% CI: 31, 43) and a CR+CRh rate of 65% (95% CI: 59, 70) compared to a CR rate of 18% (95% CI: 12, 25) and a CR+CRh rate of 23% (95% CI: 16, 30) in the placebo arm. The median time to first response of CR or CRh was 1.0 months (range: 0.6 to 14.3 months) with VENCLEXTA in combination with azacitidine. The median duration of treatment was 7.6 months (range: <0.1 to 30.7 months) in the VENCLEXTA arm.

    The most frequent ARs (≥30% with a difference between arms of ≥5%) for patients taking VENCLEXTA in combination with azacitidine were mostly hematologic and gastrointestinal in nature and consisted of, nausea (44%), diarrhea (43%), febrile neutropenia (42%), musculoskeletal pain (36%), fatigue (31%), and vomiting (30%). Serious adverse reactions were reported in 83% of patients in the VENCLEXTA arm, with the most frequent serious ARs (≥5%) being febrile neutropenia (30%), pneumonia (22%), sepsis (excluding fungal; 19%) and hemorrhage (6%).

    VIALE-C (M16-043) Phase 3 Trial1,9 

    A total of 211 patients were enrolled and treated in the randomized, double-blind, placebo-controlled, multicenter, Phase 3 VIALE-C trial, which evaluated the efficacy and safety of VENCLEXTA in combination with LDAC (n=143) versus placebo with LDAC (n=68). The primary endpoint was OS.

    VENCLEXTA in combination with LDAC did not significantly improve OS versus placebo in combination with LDAC. The HR for OS was 0.75 (95% CI: 0.52, 1.07); p-value 0.114. The median OS for VENCLEXTA in combination with LDAC arm was 7.2 months (95% CI: 5.6, 10.1) and for PBO+LDAC arm was 4.1 months (95% CI: 3.1, 8.8).

    Efficacy was based on the rate of CR and duration of CR with supportive evidence of rate of CR+CRh, duration of CR+CRh, and the rate of conversion from transfusion dependence to transfusion independence. The CR rate in the VENCLEXTA in combination with LDAC arm was 27% (95% CI: 20%, 35%) with a median duration of CR of 11.1 months (95% CI: 6.1, -), and the CR rate in the placebo arm was 7.4% (95% CI: 2.4%, 16%) with a median duration of CR of 8.3 months (95% CI: 3.1, - ). The CR+CRh rate in the VENCLEXTA in combination with LDAC arm was 47% (95% CI: 39%, 55%) and in the placebo arm was 15% (95% CI: 7.3%, 25%) with a median duration of CR+CRh of 11.1 months with VENCLEXTA in combination with LDAC and 6.2 months with LDAC in combination with placebo. The median time to first response of CR or CRh was 1.0 month (range: 0.7 to 5.8 months) with VENCLEXTA in combination with LDAC.

    The most frequent AR (≥30% with a difference between arms of ≥5%) for patients taking VENCLEXTA in combination with LDAC was nausea (42%). Serious ARs were reported in 65% of patients in the VENCLEXTA arm, with the most frequent (≥10%) being pneumonia (17%), febrile neutropenia (16%), and sepsis (excluding fungal; 12%).

    About VENCLEXTA® (venetoclax) 

    VENCLEXTA® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA targets the BCL-2 protein and works to help restore the process of apoptosis.

    VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. VENCLEXTA is approved in more than 50 countries, including the U.S.

    Uses and Important VENCLEXTA® (venetoclax) U.S. Safety Information1

    Uses

    VENCLEXTA is a prescription medicine used:

    • to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
    • in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
      • are 75 years of age or older, or

        have other medical conditions that prevent the use of standard chemotherapy.

    It is not known if VENCLEXTA is safe and effective in children.

    Important Safety Information

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

    VENCLEXTA can cause serious side effects, including:

    Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

    Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

    Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects.

    Who should not take VENCLEXTA?

    Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

    • Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
    • Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.

    Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

    • have kidney or liver problems.
    • have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
    • have a history of high uric acid levels in your blood or gout.
    • are scheduled to receive a vaccine. You should not receive a "live vaccine" before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
    • are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for at least 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
    • are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment and for 1 week after the last dose of VENCLEXTA.

    What should I avoid while taking VENCLEXTA?

    You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

    What are the possible side effects of VENCLEXTA?

    VENCLEXTA can cause serious side effects, including:

    • Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
    • Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.

    Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

    The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

    The most common side effects of VENCLEXTA in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea, diarrhea, low platelet count, constipation, low white blood cell count, fever with low white blood cell count, tiredness, vomiting, swelling of arms, legs, hands, or feet, fever, infection in lungs, shortness of breath, bleeding, low red blood cell count, rash, stomach (abdominal) pain, infection in your blood, muscle and joint pain, dizziness, cough, sore throat, and low blood pressure.

    VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

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

    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.

    The full U.S. prescribing information, including Medication Guide, for VENCLEXTA can be found here. Globally, prescribing information varies; refer to the individual country product label for complete information.

    About AbbVie in Oncology

    At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.

    About AbbVie

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

    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 2019 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.

                                                                         

    1 VENCLEXTA (venetoclax) [Package Insert]. North Chicago, IL.: AbbVie Inc.

    2 Döhner H, et al. Acute myeloid leukemia. N Engl J Med. 2015;373(12):1136-1152.

    3 American Cancer Society (2019). Typical Treatment of Most Types of Acute Myeloid Leukemia (Except Acute Promyelocytic M3). https://www.cancer.org/cancer/acute-myeloid-leukemia/treating/typical-treatment-of-aml.html. Accessed October 2020.

    4 Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.1.2021. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed October 16, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

    5 AbbVie (2018). AbbVie Receives US FDA Accelerated Approval for VENCLEXTA® (venetoclax) for Treatment of Newly-Diagnosed Acute Myeloid Leukemia Patients Ineligible for Intensive Chemotherapy. https://news.abbvie.com/news/press-releases/abbvie-receives-us-fda-accelerated-approval-for-venclexta-venetoclax-for-treatment-newly-diagnosed-acute-myeloid-leukemia-patients-ineligible-for-intensive-chemotherapy.htm. Accessed October 2020.

    6 DiNardo CD, et al. A randomized, double-blind, placeobo-controlled study of venetoclax with azacytidine vs azacytidine in treatment-naïve patients with acute myeloid leukemia ineligible for intensive therapy: VIALE-A. Presented at the EHA 25th Annual Congress.

    7 DiNardo CD, et al. Azacitidine and Venetoclax in Previously Untreated Acute Myeloid. N Engl J Med. 2020;383(7):617-629.

    8 Wei AH, et al. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial. https://ashpublications.org/blood/article/135/24/2137/454176/Venetoclax-plus-LDAC-for-newly-diagnosed-AML. Accessed October 2020.

    9 Wei AH, et al. A Phase III Study of Venetoclax Plus Low-Dose Cytarabine in Previously Untreated Older Patients with Acute Myeloid Leukemia (VIALE-C): A Six-Month Update.Presented at the 2020 ASCO Virtual Meeting.

    10 National Cancer Institute (2018). Acute Myeloid Leukemia - SEER Stat Fact Sheets. https://seer.cancer.gov/statfacts/html/amyl.html. Accessed October 2020.

    11 Pettit K, Odenike O. Defining and treating older adults with acute myeloid leukemia who are ineligible for intensive therapies. Front Oncol. 2015; 5:250.

     

    Cision View original content:http://www.prnewswire.com/news-releases/venclexta-venetoclax-receives-fda-full-approval-for-acute-myeloid-leukemia-aml-301154267.html

    SOURCE AbbVie

    View Full Article Hide Full Article
  4. IRVINE, Calif., Oct. 9, 2020 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE:ABBV), announced today that it will present 4 abstracts at the annual American Society for Dermatologic Surgery (ASDS) virtual meeting from October 9-11, 2020.

    The scheduled times (noted in local Eastern Standard Time) of the presentations, titles and authors are as follows.

    Oral presentations include:

    • Patient Satisfaction Following Chin Augmentation With Hyaluronic Acid Fillers: A Pooled Analysis
      • Authors: Joely Kaufman, Patricia Ogilvie, Kenneth Beer, Alexander Rivkin, Sarah Baradaran, Andrew Schumacher
      • Presenter: Joely Kaufman, MD
      • Saturday, October 10th, 11:27 a.m.
    • Treatment of Upper Facial Lines With OnabotulinumtoxinA Results in Long-Lasting Efficacy

    IRVINE, Calif., Oct. 9, 2020 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE:ABBV), announced today that it will present 4 abstracts at the annual American Society for Dermatologic Surgery (ASDS) virtual meeting from October 9-11, 2020.

    The scheduled times (noted in local Eastern Standard Time) of the presentations, titles and authors are as follows.

    Oral presentations include:

    • Patient Satisfaction Following Chin Augmentation With Hyaluronic Acid Fillers: A Pooled Analysis
      • Authors: Joely Kaufman, Patricia Ogilvie, Kenneth Beer, Alexander Rivkin, Sarah Baradaran, Andrew Schumacher
      • Presenter: Joely Kaufman, MD
      • Saturday, October 10th, 11:27 a.m.
    • Treatment of Upper Facial Lines With OnabotulinumtoxinA Results in Long-Lasting Efficacy and Patient Satisfaction
      • Authors: Joel L. Cohen, Koenraad De Boulle, Steven Fagien, Jean Carruthers, Sue Ellen Cox, Patricia Ogilvie, Julie Garcia, Sara Sangha
      • Presenter: Joel L. Cohen, MD
      • Sunday, October 11th, 10:27 a.m.

    The following posters will be on display and available for the entire length of the ASDS Virtual Annual Meeting.

    • Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines
      • Authors: Sue Ellen Cox, John H. Joseph, Steven Fagien, Dee Anna Glaser, Suzanne Bruce, Edward Lain, Steven Yoelin, Melanie Palm, Corey S. Maas, Xiaofang Lei, John Maltman, Sara Sangha, Mitchell Brin
    • Global Patient Perspectives on Skin Quality in Facial Aesthetics
      • Authors: Noëlle Sherber, Annie Chiu, Arisa Ortiz, Shannon Humphrey, Jeanine Downie, Sabrina Fabi

    Complete abstracts, details on presentation times and changes to presentation dates can be found on the ASDS website. The above listed dates are subject to change. Please check www.asds.net for the latest information.

    IMPORTANT SAFETY INFORMATION & APPROVED USES

    BOTOX® Cosmetic 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® Cosmetic:

    • 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.

    BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

    There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines.

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

    Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

    Do not receive BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (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.

    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® Cosmetic.

    Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic 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® Cosmetic 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® Cosmetic in the past.

    Tell your doctor if you have 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® Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.

    APPROVED USES

    BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.

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

    To report a side effect, please call Allergan at 1-800-678-1605.

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

    About Allergan Aesthetics

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

    About AbbVie

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

     

    Cision View original content:http://www.prnewswire.com/news-releases/allergan-aesthetics-to-present-data-from-4-abstracts-at-the-2020-american-society-for-dermatologic-surgery-virtual-meeting-301149140.html

    SOURCE AbbVie

    View Full Article Hide Full Article
  5. IRVINE, Calif., Oct. 7, 2020 /PRNewswire/ -- Today Allergan Aesthetics, an AbbVie company (NYSE:ABBV), announced that it has entered into an agreement with Luminera, a privately held, aesthetics company based in Israel with a portfolio and pipeline of dermal filler products. 

    Under the terms of the agreement, Allergan Aesthetics will acquire Luminera's full dermal filler portfolio and R&D pipeline further enhancing Allergan Aesthetics' leading dermal filler portfolio with its JUV DERM® collection of fillers. 

    "The addition of the Luminera assets adds innovative technology, complementing our leading JUV DERM® filler franchise.  We welcome the Luminera team as we continue to build our global aesthetics company and a world-class product offering…

    IRVINE, Calif., Oct. 7, 2020 /PRNewswire/ -- Today Allergan Aesthetics, an AbbVie company (NYSE:ABBV), announced that it has entered into an agreement with Luminera, a privately held, aesthetics company based in Israel with a portfolio and pipeline of dermal filler products. 

    Under the terms of the agreement, Allergan Aesthetics will acquire Luminera's full dermal filler portfolio and R&D pipeline further enhancing Allergan Aesthetics' leading dermal filler portfolio with its JUV DERM® collection of fillers. 

    "The addition of the Luminera assets adds innovative technology, complementing our leading JUV DERM® filler franchise.  We welcome the Luminera team as we continue to build our global aesthetics company and a world-class product offering for healthcare professionals and patients around the world," said Carrie Strom, SVP, AbbVie, and President, Global Allergan Aesthetics.

    Luminera Chairman Dadi Segal, PhD, added, "We believe bringing together key, innovative Luminera assets with the support of Allergan Aesthetics will provide an even brighter future for our people, products and a more expanded offering for our customers.  This is a tremendous opportunity to further build, develop and collaborate with a leading global aesthetics company."

    Luminera's key value driver for the future is HArmonyCa, an innovative dermal filler intended for facial soft tissue augmentation comprised of a combination of cross-linked hyaluronic acid (HA) with embedded calcium hydroxyapatite (CaHA) microspheres.  The combination of HA and CaHA in a single product is  highly differentiated in the dermal filler category. HArmonyCa is currently commercially available in Israel and Brazil.

    Allergan Aesthetics will continue to develop this product for its International and US markets.

    The Luminera dermal filler portfolio also includes a line of HA dermal fillers, as well CaHA based fillers commercialised across several markets.  Brands include Crystalys, Hydryalix and Hydryal.

    About Allergan Aesthetics

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

    About AbbVie

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

    Cision View original content:http://www.prnewswire.com/news-releases/allergan-aesthetics-an-abbvie-company-acquires-innovative-luminera-dermal-filler-business-301147404.html

    SOURCE AbbVie

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