R&D News

NORTH CHICAGO, Ill. and NEW YORK, Sept. 22, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Bristol-Myers Squibb Company (NYSE: BMY) today announced a clinical trial collaboration to evaluate the combination of AbbVie's investigational antibody drug conjugate ABBV-399 and Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC). 

NORTH CHICAGO, Ill., Sept. 18, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint. Results showed that VENCLEXTA/VENCLYXTO in combination with Rituxan prolonged progression-free survival (PFS) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) compared with bendamustine combined with Rituxan. An independent data monitoring committee reviewed this study and made the recommendation to unblind the trial based on the positive results. Doctors will continue to monitor patients who remain active in the MURANO trial in efforts to obtain additional, longer-term safety and efficacy information. 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.

NORTH CHICAGO, Ill., Sept. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-BEYOND clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond or were intolerant to treatment with biologic DMARDs (bDMARDs).¹ Results showed that after 12 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20* and low disease activity (LDA)**.¹ All ranked secondary endpoints were also achieved with both doses.¹ Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established.

NORTH CHICAGO, Ill., Sept. 7, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 2b randomized, placebo-controlled, dose-ranging study of upadacitinib (ABT-494), an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis not adequately controlled by topical treatments, or for whom topical treatments were not medically advisable.¹ In this study, all upadacitinib dose groups (30/15/7.5 mg once-daily) met the primary endpoint (mean percent change in EASI at week 16 versus placebo).¹ Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established.

NORTH CHICAGO, Ill., Sept. 6, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being evaluated for the management of endometriosis with associated pain.  In two replicate Phase 3 clinical studies, elagolix demonstrated superiority compared to placebo in reducing three types of endometriosis-associated pain – daily menstrual pelvic pain, non-menstrual pelvic pain and painful intercourse.

NORTH CHICAGO, Ill., June 23, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET™ (glecaprevir/pibrentasvir), an investigational, pan-genotypic treatment for adults with chronic hepatitis C virus (HCV) infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6), who comprise the majority of people living with HCV.¹ The European Commission will now review the CHMP opinion and a final decision is expected in Q3 2017.

- First oral presentation of full Phase 2 trial results with overall response rate (ORR), inclusive of complete and partial remission rates(1)

- New data of rheumatoid arthritis patients who participated in a HUMIRA (adalimumab) patient support program in select countries showed an association between the use of a patient support program and improvements in functional outcomes

NORTH CHICAGO, Ill. and SOUTH SAN FRANCISCO, Calif., June 13, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, and Principia Biopharma Inc., a private, clinical-stage biopharmaceutical company, announced today that they have entered a collaboration for the development of oral immunoproteasome inhibitors.  The collaboration is aimed at developing first-in-class oral therapies that bring the power of proteasome inhibition safely into the field of immunology. 

- Results from pivotal VENCLYXTO ™ (venetoclax) trial in relapsed/refractory chronic lymphocytic leukemia (CLL) patients with 17p deletion to be presented