ABBV AbbVie Inc.

114.7
-0.03  -0%
Previous Close 114.73
Open 114.49
52 Week Low 79.1101
52 Week High 118.28
Market Cap $202,585,701,939
Shares 1,766,222,336
Float 1,764,699,614
Enterprise Value $275,548,070,648
Volume 4,360,179
Av. Daily Volume 6,412,997
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Upcoming Catalysts

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

Drug Stage Notes
ABICIPAR
Age-related macular degeneration (AMD)
CRL
CRL
CRL issued June 26, 2020.
RINVOQ (Upadacitinib) - U-ACHIEVE
Ulcerative colitis
Phase 3
Phase 3
Phase 3 trial met primary and secondary endpoints - December 9, 2020.
Depatuxizumab mafodotin (ABT-414)
Glioblastoma (rGBM)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint at interim analysis - May 17, 2019.
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) - MOTIVATE
Crohn’s Disease
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 7, 2021.
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.
UBRELVY (Ubrogepant)
Migraine
Approved
Approved
FDA Approval announced December 23, 2019.
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., June 17, 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 August 16, 2021 to stockholders of record at the close of business on July 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…

    NORTH CHICAGO, Ill., June 17, 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 August 16, 2021 to stockholders of record at the close of business on July 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:http://www.prnewswire.com/news-releases/abbvie-declares-quarterly-dividend-301315157.html

    SOURCE AbbVie

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  2. SHANGHAI, June 16, 2021 /PRNewswire/ -- Zhongchao Inc. (NASDAQ:ZCMD) ("Zhongchao" or the "Company"), a healthcare services company offering online healthcare information, professional training and educational services, today announced the cooperation in physician education with AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd. ("AbbVie Shanghai"), a subsidiary of AbbVie Inc (NYSE:ABBV) ("AbbVie"). AbbVie is a research-based global biopharmaceutical company. Pursuant to an agreement to facilitate such cooperation, Zhongchao and AbbVie Shanghai will cooperate in, including but not limited to, developing the medical education contents and producing medical education courses.

    Weiguang Yang, Chairman and Chief Executive Officer of Zhongchao, commented…

    SHANGHAI, June 16, 2021 /PRNewswire/ -- Zhongchao Inc. (NASDAQ:ZCMD) ("Zhongchao" or the "Company"), a healthcare services company offering online healthcare information, professional training and educational services, today announced the cooperation in physician education with AbbVie Pharmaceutical Trading (Shanghai) Co., Ltd. ("AbbVie Shanghai"), a subsidiary of AbbVie Inc (NYSE:ABBV) ("AbbVie"). AbbVie is a research-based global biopharmaceutical company. Pursuant to an agreement to facilitate such cooperation, Zhongchao and AbbVie Shanghai will cooperate in, including but not limited to, developing the medical education contents and producing medical education courses.

    Weiguang Yang, Chairman and Chief Executive Officer of Zhongchao, commented, "AbbVie is one of the top ten global research-oriented biopharmaceutical companies with numerous innovations in the core field of immunology, oncology, neuroscience, and Allergan Aesthetics. In recent years, AbbVie has introduced more and more innovative therapies and drugs to the Chinese market, benefitting Chinese patients. We are honored to cooperate with AbbVie Shanghai to promote the development of medical education."

    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. They 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 www.abbvie.com.

    About Zhongchao Inc.

    Incorporated in 2012 with headquarter offices in Shanghai and Beijing, China, Zhongchao Inc. is an online provider of healthcare information, professional training and educational services to healthcare professionals under its "MDMOOC" platform (www.mdmooc.org) and to the public under its "Sunshine Health Forums" platform (www.ygjkclass.com) in China. More information about the Company can be found at its investor relations website at http://izcmd.com.

    Safe Harbor Statement

    This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as "may," "will," "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following:  the Company's goals and strategies; the Company's future business development; product and service demand and acceptance; changes in technology; economic conditions; the growth of the professional training and educational services market in China and the other international markets the Company plans to serve; reputation and brand; the impact of competition and pricing; government regulations; fluctuations in general economic and business conditions in China and the international markets the Company plans to serve and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the SEC, the length and severity of the recent coronavirus outbreak, including its impacts across our business and operations.  For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward–looking statements to reflect events or circumstances that arise after the date hereof.

    For more information, please contact:

    At the Company: Pei Xu, CFO

    Email:

    Phone: +86 21-3220-5987

    Investor Relations: Sherry Zheng 

    Weitian Group LLC

    Email:

    Phone: +1 718-213-7386

    Cision View original content:http://www.prnewswire.com/news-releases/zhongchao-inc-partners-with-a-subsidiary-of-abbvie-inc-nyse-abbv-for-medical-education-services-301313255.html

    SOURCE Zhongchao Inc.

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  3. NORTH CHICAGO, Ill., June 12, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced new data from the Phase 3 GLOW study comparing the efficacy and safety of the combination of IMBRUVICA® (ibrutinib) plus VENCLEXTA®/VENCLYXTO® (venetoclax) (I+V) versus chlorambucil plus obinutuzumab (C+O) for first-line treatment in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had active disease requiring treatment per the International Workshop on CLL (iwCLL) criteria. The study met its primary endpoint of superior progression-free survival (PFS) as assessed by an independent review committee (IRC) with a HR 0.216 (95% CI, 0.131-0.357; p < 0.0001), demonstrating a reduction in the risk of disease progression or death for I+V of approximately 78% compared to C+O. I+V is the first all-oral, once-daily, chemotherapy-free, fixed-duration investigational combination. Results of the study will be presented at the European Hematology Association (EHA) 2021 Virtual Congress (Abstract #LB1902) during late-breaking abstract session on June 12 from 4:00-5:30 p.m. CEST.

    The PFS benefit with I+V was consistent across pre-specified subgroups, including patients 65 years and older and those with comorbidities (CIRS >6). The median PFS for C+O was 21 months while the median PFS for I+V had not been reached at the time of analysis. The safety profile of I+V was generally consistent with the safety profile of the single agents and tolerability profiles were consistent with CLL treatment in the enrolled patient population.

    "With CLL being one of the most common types of blood cancer, the expansion of research into additional treatment options for patients is an important clinical undertaking," said Arnon Kater, M.D., Ph.D., deputy head of hematology, University of Amsterdam Faculty of Medicine. "The progression-free survival findings of ibrutinib and venetoclax in the GLOW study are promising and show the potential to become an additional treatment option for people living with CLL."

    Secondary endpoints included rates of undetectable minimal residual disease (uMRD), complete response rate (CR) and overall response rate (ORR). The rate of uMRD in the bone marrow as assessed by next generation sequencing was significantly higher for patients treated with I+V compared to those treated with C+O (p<0.0001). Three months after the completion of treatment uMRD was observed in 51.9% and 17.1%, respectively. Peripheral blood (PB) uMRD persisted 12 months after end of treatment in 49% with I+V and 12% with C+O. The CR rate was also significantly higher with I+V vs. C+O (38.7% vs. 11.4%) (p < 0.0001). The ORR was not significantly different between I+V and C+O treated groups. Time to subsequent therapy was longer for I+V (HR 0.143, 95% CI 0.05-0.41).

    "We are encouraged by these results, which further support the efficacy of these two well-established therapies," said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. "We remain steadfast in our commitment to continue the research and development of this combination as a potential treatment for CLL with the ultimate goal to put patients into remission with a fixed-duration, oral therapy."

    The safety profile of I+V was generally consistent with the safety profile of the single agents and tolerability profiles were consistent with CLL treatment in the enrolled patient population. Most common grade ≥3 treatment-emergent adverse events (AEs) were neutropenia (34.9%), infections (17%), and diarrhea (10.4%) for I+V; neutropenia (49.5%), infections (11.4%), and thrombocytopenia (20%) for C+O. At time of analysis, overall survival was immature; there were eleven deaths in the fixed-duration I+V arm and twelve in the C+O arm. Deaths during treatment occurred in seven patients on I+V and two patients on C+O. 

    Results from the ongoing Phase 2 CAPTIVATE study, assessing the I+V combination for first-line treatment of patients with CLL or SLL (PCYC-1142), were presented at the 2021 American Society of Clinical Oncology Annual Meeting (Abstract #7501) and the EHA 2021 Virtual Congress.

    About CLL

    CLL is one of the two most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes). While these cancer cells start in the bone marrow, they later spread into the blood. There are approximately 195,129 people with CLL living in the United States with more than 21,000 newly diagnosed patients in 2021.1,2 CLL is predominately a disease of the elderly, with a median age at diagnosis of 70 years and is more common among men than women.3 

    About the GLOW Study

    The GLOW study is a randomized, open label Phase 3 trial comparing progression-free survival in patients treated with either I+V or C+O as assessed by an Independent Review Committee. It enrolled patients (pts) aged ≥65 years or 18-64 years with cumulative illness rating scale score >6 or creatinine clearance <70 mL/min who had active disease requiring treatment per the International Workshop on CLL (iwCLL) criteria. Patients with del(17p) or known TP53 mutations were excluded. There were 211 patients randomly assigned in a 1:1 ratio to receive either I+V (106) and or C+O (105) and the median age was 71 years. Patients assigned to I+V received treatment for 15 cycles (1 cycle is 28 days), starting with three cycles of ibrutinib monotherapy lead-in followed by the combination of I+V for 12 cycles. Patients assigned to C+O were treated for six cycles.

    About IMBRUVICA® (Ibrutinib)

    IMBRUVICA® (ibrutinib) is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company, and Janssen Biotech, Inc. (Janssen). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.4,5 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.6

    Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; Waldenström macroglobulinemia; previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.7

    IMBRUVICA is now approved in more than 100 countries and has been used to treat more than 230,000 patients worldwide across its approved indications. IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA. This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

    Since 2019, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA®) as a preferred regimen for the initial treatment of CLL/SLL and has Category 1 treatment status for treatment-naïve patients without deletion 17p. Since January 2020, the NCCN Guidelines® have categorized IMBRUVICA with or without rituximab as a preferred regimen for the treatment of relapsed/refractory MCL. As of September 2020, the NCCN guidelines were updated to reflect IMBRUVICA with or without rituximab as the only Category 1 preferred regimen for both untreated and previously treated WM patients.

    IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. For more information, visit www.IMBRUVICA.com 

    *Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

    About VENCLEXTA®/VENCLYXTO® (venetoclax)

    VENCLEXTA®/VENCLYXTO® (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. VENCLXEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

    VENCLEXTA/VENCLYXTO 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 cancers. Venetoclax is approved in more than 80 countries, including the U.S.

    IMPORTANT SAFETY INFORMATION

    US IMBRUVICA® Important Side Effect Information7 

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

    • have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA® for any planned medical, surgical, or dental procedure.
    • have bleeding problems.
    • have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
    • have an infection.
    • have liver problems.
    • are pregnant or plan to become pregnant. IMBRUVICA® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA®. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA®.
      • Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA® and for 1 month after the last dose.
      • Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA® and for 1 month after the last dose.
    • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA® and for 1 week after the last dose.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA® with certain other medicines may affect how IMBRUVICA® works and can cause side effects. 

    How should I take IMBRUVICA®? 

    • Take IMBRUVICA® exactly as your healthcare provider tells you to take it.
    • Take IMBRUVICA® 1 time a day.
    • Swallow IMBRUVICA® capsules or tablets whole with a glass of water.
    • Do not open, break or chew IMBRUVICA® capsules.
    • Do not cut, crush or chew IMBRUVICA® tablets.
    • Take IMBRUVICA® at about the same time each day.
    • If you miss a dose of IMBRUVICA® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA® at your regular time on the next day. Do not take extra doses of IMBRUVICA® to make up for a missed dose.
    • If you take too much IMBRUVICA® call your healthcare provider or go to the nearest hospital emergency room right away.

    What should I avoid while taking IMBRUVICA®? 

    • You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA®. These products may increase the amount of IMBRUVICA® in your blood.

    What are the possible side effects of IMBRUVICA®?

    IMBRUVICA® may cause serious side effects, including: 

    • Bleeding problems (hemorrhage)are common during treatment with IMBRUVICA®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache. 
    • Infections can happen during treatment with IMBRUVICA®. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA®.
    • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA®, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
    • Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation, and atrial flutter), heart failure, and death have happened in people treated with IMBRUVICA®, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles, or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA® dose.
    • High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
    • Second primary cancers. New cancers have happened during treatment with IMBRUVICA®, including cancers of the skin or other organs.
    • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

    The most common side effects of IMBRUVICA® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include: 

    • diarrhea
    • tiredness
    • muscle and bone pain
    • rash
    • bruising

    The most common side effects of IMBRUVICA® in adults with cGVHD include: 

    • tiredness
    • bruising
    • diarrhea
    • mouth sores (stomatitis)
    • muscle spasms
    • nausea
    • pneumonia

    Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away. 

    These are not all the possible side effects of IMBRUVICA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

    General information about the safe and effective use of IMBRUVICA® 

    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA® for a condition for which it was not prescribed. Do not give IMBRUVICA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA® that is written for health professionals. 

    Pleaseclick herefor full Prescribing Information.

    Uses of VENCLEXTA® (venetoclax) in US

    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 VENCLEXTA® (venetoclax) US Safety Information

    US VENCLEXTA® Important Safety Information8 

    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. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose. 

    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 with VENCLEXTA and for 1 week after the last dose.

    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 side effects of prescription drug to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 

    If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance. 

    The full U.S. prescribing information, including Medication Guide, for VENCLEXTA® can be found here.  

    Indications and Important VENCLYXTO® (venetoclax) EU Safety Information9

    Indication 

    Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

    Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

    Venclyxto monotherapy is indicated for the treatment of CLL:

    • In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
    • In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

    Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

    Contraindications

    Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John's wort as Venclyxto efficacy may be reduced.

    Special Warnings & Precautions for Use

    Tumour Lysis syndrome, including fatal events, has occurred in patients when treated with Venclyxto. For CLL and AML, please refer to the indication-specific recommendations for prevention of TLS in the Venclyxto summary of product characteristic (SmPC). 

    Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS. The risk of TLS is a continuum based on multiple factors, including comorbidities. Venclyxto poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venclyxto and at each dose increase.

    Neutropenia (grade 3 or 4) has been reported. Complete blood counts should be monitored throughout the treatment period. 

    In patients with AML, neutropenia (grade 3 or 4) is common before starting treatment. The neutrophil counts can worsen with Venetoclax in combination with a hypomethylating agent. Neutropenia can recur with subsequent cycles of therapy. Dose modification and interruptions for cytopenias are dependent on remission status.



    For CLL and AML, please refer to the indication-specific recommendations for dose modifications for toxicities in the Venclyxto SmPC.

    Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment including antimicrobials and dose interruption or reduction as appropriate.  

    Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

    Drug Interactions

    In CLL and AML CYP3A inhibitors may increase Venclyxto plasma concentrations.

    In CLL, at initiation and dose-titration phase, strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, please refer to the recommendations for dose modifications in the Venclyxto SmPC.

    In AML, please refer to the AML-specific recommendation for dose modifications for potential interactions with CYP3A inhibitors, in the Venclyxto SmPC.

    Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.

    CYP3A4 inducers may decrease Venclyxto plasma concentrations. Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations. 

    Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

    Adverse Reactions

    CLL

    The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

    The most frequently occurring serious adverse reactions (>=2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (>=2%) were pneumonia and febrile neutropenia.

    Discontinuations due to adverse reactions occurred in 16% of patients treated with venetoclax in combination with obinutuzumab or rituximab in the CLL14 and Murano studies, respectively. In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions. 

    Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in CLL14, in 15% of patients treated with the combination of venetoclax and rituximab in Murano, and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia. 

    AML

    The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in combination with azacitidine or decitabine in the VIALE-A and M14-358, respectively, were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite, haemorrhage, dizziness/syncope, hypotension, headache, abdominal pain, and anaemia.

    The most frequently reported serious adverse reactions (≥5%) in patients receiving venetoclax in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, the most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.

    Discontinuations due to adverse reactions occurred in 24% of patients treated with venetoclax in combination with azacitidine in the VIALE-A study, and 26% of patients treated with venetoclax in combination with decitabine in the M14-358 study, respectively.

    Dosage reductions due to adverse reactions occurred in 2% of patients in VIALE-A, and in 6 % of patients in M14-358. Venetoclax dose interruptions due to adverse reactions occurred in 72% and 65 % of patients, respectively. The most common adverse reaction that led to dose interruption (>10%) of Venetoclax in VIALE-A, were febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia. The most common adverse reactions that led to dose interruption (≥5%) of venetoclax in M14-358 were febrile neutropenia, neutropenia/neutrophil count decreased, pneumonia, platelet count decreased, and white blood cell count decreased.

    Special Populations

    Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.

    For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.

    Venclyxto may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.

    This is not a complete summary of all safety information. See VENCLYXTO® full summary of product characteristics (SmPC) athttps://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdfGlobally, 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 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 IMS Database [Data on File]. 

    2 National Cancer Institute. Cancer Stat Facts: Leukemia - Chronic Lymphocytic Leukemia (CLL). https://seer.cancer.gov/statfacts/html/clyl.html. Accessed May 2021. 

    3 Shanafelt, et al. Age at Diagnosis and the Utility of Prognostic Testing in Patients with Chronic Lymphocytic Leukemia (CLL). Cancer. 2010; 116(20): 4777–4787.

    4 Genetics Home Reference. Isolated growth hormone deficiency.  http://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency. Accessed November 2020.

    5 Turetsky, et al. Single cell imaging of Bruton's Tyrosine Kinase using an irreversible inhibitor. Scientific Reports. volume 4, Article number: 4782 (2014)

    6 de Rooij MF, Kuil A, Geest CR, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012;119(11):2590-2594.

    7 IMBRUVICA U.S. Prescribing Information.

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

    9 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.

    Cision View original content:http://www.prnewswire.com/news-releases/imbruvica-ibrutinib-plus-venclextavenclyxto-venetoclax-combination-shows-superior-progression-free-survival-compared-to-chlorambucil-plus-obinutuzumab-in-first-line-chronic-lymphocytic-leukemia-cll-phase-3-glow-study-301311176.html

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  4. NORTH CHICAGO, Ill., June 11, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced results from a four-year follow-up analysis of the Phase 3 CLL14 trial, which showed that previously untreated patients with chronic lymphocytic leukemia (CLL) with coexisting conditions who were treated with VENCLYXTO®/VENCLEXTA® (venetoclax) plus obinutuzumab continued to show longer progression-free survival (PFS) and higher rates of undetectable minimal residual disease (MRD) compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil. The data were presented for the first time today during the virtual 26th European Hematology Association (EHA) Annual Congress (abstract #S146).

    "The CLL14 trial results…

    NORTH CHICAGO, Ill., June 11, 2021 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced results from a four-year follow-up analysis of the Phase 3 CLL14 trial, which showed that previously untreated patients with chronic lymphocytic leukemia (CLL) with coexisting conditions who were treated with VENCLYXTO®/VENCLEXTA® (venetoclax) plus obinutuzumab continued to show longer progression-free survival (PFS) and higher rates of undetectable minimal residual disease (MRD) compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil. The data were presented for the first time today during the virtual 26th European Hematology Association (EHA) Annual Congress (abstract #S146).

    "The CLL14 trial results observed after four years of follow-up with treatment of venetoclax plus obinutuzumab show that these patients can experience long-lasting responses without disease progression, years after stopping treatment," said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie.

    After a median follow-up of more than four years (52.4 months), patients treated with the VENCLYXTO/VENCLEXTA and obinutuzumab combination (n=216) continued to demonstrate longer PFS compared to patients on treatment with obinutuzumab and chlorambucil, the risk of disease progression or death was reduced by 67 percent (n=216; median not reached compared to 36.4 months; hazard ratio [HR] 0.33 [95% CI 0.25-0.45]); results are descriptive. At four years after randomization, the PFS rate for patients treated with the VENCLYXTO/VENCLEXTA-based combination was 74 percent compared to 35.4 percent for patients treated with obinutuzumab and chlorambucil. The improvement in PFS was observed across all clinical and biological risk groups, including patients with TP53 mutation, 17p deletion and unmutated IGHV status.1

    Additionally, assessment of MRD in peripheral blood 30 months after the end of treatment showed that 26.9 percent of patients treated with the VENCLYXTO/VENCLEXTA-based combination still had undetectable MRD (<10-4) compared to 3.2 percent of patients in the obinutuzumab plus chlorambucil arm.1 Undetectable MRD occurs when less than one CLL cell per 10,000 lymphocytes can be detected in the blood or bone marrow using sensitive analytical methods.

    No new safety signals were observed in the four-year follow-up analysis.1  The most frequently occurring serious adverse reactions (>=2%) in patients receiving venetoclax in combination with obinutuzumab were pneumonia, sepsis, febrile neutropenia, and TLS.3

    "CLL is considered an incurable disease and becomes more difficult to treat each time a patient experiences a relapse, so a key treatment goal is to maintain remission for as long as possible. The four- year results of the CLL14 study show that 74 percent of patients treated with fixed-duration venetoclax-obinutuzumab remain without PFS event, more than three years after treatment cessation," said Othman Al-Sawaf, M.D., lead investigator of the CLL14 study, hematologist-oncologist at the University Hospital Cologne in Germany, and study physician at the German CLL Study Group. "This highlights how durable the remissions are after 12 treatment cycles in the vast majority of patients, suggesting the venetoclax-obinutuzumab combination regimen as an effective option for patients with previously untreated CLL."

    CLL is a slow-growing form of leukemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow. CLL is the most common form of leukemia in the Western Hemisphere, accounting for approximately one third of new leukemia diagnoses and nearly 95,000 new cases in Europe each year.4,5,6 

    VENCLYXTO/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.

    About the CLL14 Phase 3 Trial3,7,8

    The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (DCLLSG), evaluated the efficacy and safety of a combined regimen of VENCLYXTO/VENCLEXTA and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously untreated patients with CLL and coexisting medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance <70 mL/min). The therapies were administered for a fixed duration of 12 months for VENCLYXTO/VENCLEXTA in combination with six cycles of obinutuzumab. The trial enrolled 432 patients, all of whom were previously untreated according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Efficacy was based on PFS as assessed by an independent review committee.

    Key secondary endpoints were rates of MRD in peripheral blood and bone marrow, overall and complete response rates, MRD in complete response in peripheral blood and bone marrow, and overall survival.

    The four-year, follow-up analysis showed an OS rate of 85.4% with Ven-Obi versus 83.1% with chlorambucil in combination with obinutuzumab (Obi-Clb; HR 0.85, 95% CI [0.54-1.35]; P=0.49).

    In patients with CLL receiving combination therapy with obinutuzumab, serious adverse reactions (ARs) were most often due to febrile neutropenia and pneumonia (5 percent each). The most common ARs (≥20 percent) of any grade were neutropenia (60 percent), diarrhea (28 percent), and fatigue (21 percent). Fatal ARs that occurred in the absence of disease progression and with onset within 28 days of the last study treatment were reported in 2 percent (4/212) of patients, most often from infection.

    About VENCLYXTO® (venetoclax) 

    VENCLYXTO® (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. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

    VENCLYXTO 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. Venetoclax is approved in more than 80 countries, including the U.S.

    Indication and Important VENCLYXTO (venetoclax) EU Safety Information3

    Indications

    Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

    Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

    Venclyxto monotherapy is indicated for the treatment of CLL:

    • In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
    • In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.

    Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

    Contraindications

    Hypersensitivity to the active substance or to any of the excipients is contraindicated. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase due to increased risk for tumour lysis syndrome (TLS). Concomitant use of preparations containing St. John's wort as Venclyxto efficacy may be reduced.

    Special Warnings & Precautions for Use

    Tumour Lysis syndrome, including fatal events, has occurred in patients when treated with Venclyxto. For CLL and AML, please refer to the indication-specific recommendations for prevention of TLS in the Venclyxto summary of product characteristic (SmPC).

    Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS. The risk of TLS is a continuum based on multiple factors, including comorbidities. Venclyxto poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of Venclyxto and at each dose increase.

    Neutropenia (grade 3 or 4) has been reported. Complete blood counts should be monitored throughout the treatment period.

    In patients with AML, neutropenia (grade 3 or 4) is common before starting treatment. The neutrophil counts can worsen with Venetoclax in combination with a hypomethylating agent. Neutropenia can recur with subsequent cycles of therapy. Dose modification and interruptions for cytopenias are dependent on remission status.

    For CLL and AML, please refer to the indication-specific recommendations for dose modifications for toxicities in the Venclyxto SmPC.

    Serious infections including sepsis with fatal outcome have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment including antimicrobials and dose interruption or reduction as appropriate.                                 

    Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

    Drug Interactions

    In CLL and AML CYP3A inhibitors may increase Venclyxto plasma concentrations.

    In CLL, at initiation and dose-titration phase, Strong CYP3A inhibitors are contraindicated due to increased risk for TLS and moderate CYP3A inhibitors should be avoided. If moderate CYP3A inhibitors must be used, please refer to the recommendations for dose modifications in the Venclyxto SmPC.

    In AML, please refer to the AML-specific recommendation for dose modifications for potential interactions with CYP3A inhibitors, in the VENCLYXTO SmPC.

    Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase.

    CYP3A4 inducers may decrease Venclyxto plasma concentrations.  Avoid coadministration with strong or moderate CYP3A inducers. These agents may decrease venetoclax plasma concentrations. 

    Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO.

    Adverse Reactions

    CLL

    The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab or rituximab were neutropenia, diarrhoea, and upper respiratory tract infection. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

    The most frequently occurring serious adverse reactions (>=2%) in patients receiving venetoclax in combination with obinutuzumab or rituximab were pneumonia, sepsis, febrile neutropenia, and TLS.  In the monotherapy studies, the most frequently reported serious adverse reactions (>=2%) were pneumonia and febrile neutropenia.

    Discontinuations due to adverse reactions occurred in 16% of patients treated with venetoclax in combination with obinutuzumab or rituximab in the CLL14 and Murano studies, respectively.  In the monotherapy studies with venetoclax, 11% of patients discontinued due to adverse reactions. 

    Dosage reductions due to adverse reactions occurred in 21% of patients treated with the combination of venetoclax and obinutuzumab in CLL14, in 15% of patients treated with the combination of venetoclax and rituximab in Murano, and in 14% of patients treated with venetoclax in the monotherapy studies. The most common adverse reaction that led to dose interruptions was neutropenia. 

    AML

    The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in combination with azacitidine or decitabine in the VIALE-A and M14-358, respectively, were thrombocytopenia, neutropenia, febrile neutropenia, nausea, diarrhoea, vomiting, anaemia, fatigue, pneumonia, hypokalaemia, and decreased appetite, haemorrhage, dizziness/syncope, hypotension, headache, abdominal pain, and anaemia.

    The most frequently reported serious adverse reactions (≥5%) in patients receiving venetoclax in combination with azacitidine were febrile neutropenia, pneumonia, sepsis and haemorrhage. In M14-358, the most frequently reported serious adverse reactions (≥5%) were febrile neutropenia, pneumonia, bacteraemia and sepsis.

    Discontinuations due to adverse reactions occurred in 24% of patients treated with venetoclax in combination with azacitidine in the VIALE-A study, and 26% of patients treated with venetoclax in combination with decitabine in the M14-358 study, respectively.

    Dosage reductions due to adverse reactions occurred in 2% of patients in VIALE-A, and in 6% of patients in M14-358. Venetoclax dose interruptions due to adverse reactions occurred in 72% and 65% of patients, respectively. The most common adverse reaction that led to dose interruption (>10%) of Venetoclax in VIALE-A, were febrile neutropenia, neutropenia, pneumonia, and thrombocytopenia.  The most common adverse reactions that led to dose interruption (≥5%) of venetoclax in M14-358 were febrile neutropenia, neutropenia/neutrophil count decreased, pneumonia, platelet count decreased, and white blood cell count decreased.

    Special Populations

    Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase.  Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined.

    For patients with severe (Child-Pugh C) hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended.

    Venclyxto may cause embryo-fetal harm when administered to a pregnant woman. Advise nursing women to discontinue breastfeeding during treatment.

    This is not a complete summary of all safety information. See Venclyxto (venetoclax) SmPC at www.ema.europa.eu. 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 TwitterFacebook, InstagramYouTube 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, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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 Al-Sawaf O, et al. Venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: 4-year follow-up analysis of the randomized CLL14 study. Presented at the European Hematology Association Annual Meeting; June 11, 2021.

    2 Hallek M, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018;131(25):2745-2760.

    3 Summary of Product Characteristics for VENCLYXTO (venetoclax). Ludwigshafen, Germany: AbbVie Deutschland GmbH & Co. KG.

    4 International Agency for Research on Cancer. World Health Organization. Europe Globocan 2018. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf. Accessed February 2020.

    5 NCI Dictionaries. NCI Dictionary of Terms. Chronic Lymphocytic Leukemia. https://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed January 2020.

    6 World Health Organization. 2014 Review of Cancer Medicines on the WHO List of Essential Medicines. http://www.who.int/selection_medicines/committees/expert/20/applications/CLL.pdf. Accessed January 2020.

    7 VENCLEXTA (venetoclax) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

    8 Fischer K, et al. Venetoclax and obinutuzumab in patients with CLL and coexisting conditions. N Engl J Med. 2019;380:2225-2236.

     

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    • Leverages Caraway's unique drug discovery platform and expertise in cellular clearance
    • Collaboration to focus on development of TMEM175 modulators in Parkinson's disease and other neurodegenerative disorders

    Caraway Therapeutics today announced an exclusive, collaboration and option agreement with AbbVie (NYSE:ABBV) to develop and commercialize Caraway's small molecule therapeutics targeting TMEM175, a potassium ion channel critical to lysosomal function implicated in both Parkinson's disease (PD) and other neurodegenerative disorders.

    TMEM175 is a compelling target with strong genetic support. Loss of function mutations in TMEM175 are associated with reduced lysosomal efficiency in a subpopulation of PD patients, that can manifest as…

    • Leverages Caraway's unique drug discovery platform and expertise in cellular clearance
    • Collaboration to focus on development of TMEM175 modulators in Parkinson's disease and other neurodegenerative disorders

    Caraway Therapeutics today announced an exclusive, collaboration and option agreement with AbbVie (NYSE:ABBV) to develop and commercialize Caraway's small molecule therapeutics targeting TMEM175, a potassium ion channel critical to lysosomal function implicated in both Parkinson's disease (PD) and other neurodegenerative disorders.

    TMEM175 is a compelling target with strong genetic support. Loss of function mutations in TMEM175 are associated with reduced lysosomal efficiency in a subpopulation of PD patients, that can manifest as earlier age of disease onset or elevated risk of dementia relative to idiopathic PD. Under this collaboration, Caraway will continue to advance proprietary small molecule TMEM175 modulators, leveraging Caraway's unique drug discovery platform and expertise in lysosomal biology and cellular clearance mechanisms, and combine with AbbVie's expertise in disease biology, clinical development, and global commercialization.

    "TMEM175 is a compelling genetically validated target for which Caraway has developed a promising drug discovery program. Collaborating with Caraway to advance TMEM175 modulators has great potential to fit with AbbVie's efforts to develop transformative treatments for patients with neurodegenerative diseases," said Eric Karran, Ph.D., Vice President, Neuroscience Discovery at AbbVie.

    "We are delighted to partner with AbbVie on Caraway's TMEM175 pipeline program for Parkinson's disease and other neurodegenerative disorders," said Martin D. Williams, Chief Executive Officer of Caraway Therapeutics. "Variants in TMEM175 that reduce lysosomal function are highly prevalent genetic risk factors for the development of PD and evidence suggests that patients with reduced TMEM175 function tend to have earlier age of disease onset and increased risk of dementia. We are looking forward to collaborating with AbbVie to develop novel TMEM175 modulators and bring new hope to patients suffering from Parkinson's and other neurodegenerative disorders."

    Under the terms of the agreement, Caraway will receive an upfront cash payment of $17 million. After Caraway completes certain pre-clinical research and development activities for the collaboration program, AbbVie has an option to license the program and proceed into IND-enabling studies, clinical development, and commercialization.

    Caraway is eligible to receive up to $267 million in payments, including upfront and future option payments, and development milestones. Caraway is also eligible to receive additional regulatory and commercial milestones, tiered royalties on global commercial sales, and has the option to participate in product development in return for higher royalty rates.

    Caraway is a portfolio company of AbbVie Ventures.

    About Caraway Therapeutics

    Caraway Therapeutics is a biopharmaceutical company pursuing novel approaches for the treatment of genetically defined neurodegenerative and rare diseases. The company is a leader in the cutting-edge science of activating cellular recycling processes to clear toxic materials and defective cellular components by modulating lysosomal function. Caraway is utilizing its unique product engine with proprietary insights into lysosomal function and small molecule ion channel modulation to develop a robust pipeline of precision therapeutic candidates with disease-modifying potential for patients. The company is backed by top-tier investors, including SV Health Investors, AbbVie Ventures, MRLV Fund, Amgen Ventures, Dementia Discovery Fund, Alexandria Venture Investments and Eisai Innovation.

    Caraway is based in Cambridge, MA. For more information, please visit www.carawaytx.com.

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