NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis.
NORTH CHICAGO, Ill., Dec. 5, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. For patients currently on treatment with Rova-T in TAHOE, the IDMC recommended that investigators and patients make individual decisions as to whether or not to continue treatment based on patient level response. The recommendation from the IDMC to halt enrollment applies only to the TAHOE study and does not impact other Rova-T clinical studies.
NORTH CHICAGO, Ill., Nov. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that data from nearly 40 abstracts, including 13 oral presentations and more than 20 poster presentations, will be presented during the upcoming 60th ASH Annual Meeting & Exposition, December 1-4, in San Diego.
NORTH CHICAGO, Ill., Nov. 14, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today presented for the first time additional results from two replicate pivotal Phase 3 clinical trials (ELARIS UF-1 (M12-815) and ELARIS UF-2 (M12-817)) evaluating the efficacy and safety of elagolix in women with uterine fibroids. These results were presented at the 47th American Association of Gynecologic Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology in Las Vegas, NV.
NORTH CHICAGO, Ill., Oct. 31, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive results from CLL14, a Phase 3, randomized clinical trial evaluating venetoclax plus obinutuzumab versus obinutuzumab plus chlorambucil, a standard of care, in patients with chronic lymphocytic leukemia (CLL) and coexisting medical conditions who have not received a prior treatment. The study met its primary endpoint of investigator-assessed progression-free survival (PFS; the time on treatment without disease progression or death1) with a 12-month fixed duration of treatment. Preliminary analysis suggests the safety profile observed in the combination of venetoclax plus obinutuzumab is consistent with the known safety profile of each medicine alone.
NORTH CHICAGO, Ill., Oct. 23, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from the ongoing Phase 3 SELECT-MONOTHERAPY trial evaluating upadacitinib (15 mg and 30 mg, once-daily), an investigational JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate.1 Improvements in physical function, health-related quality of life, pain and morning joint stiffness were reported after 14 weeks of treatment with upadacitinib monotherapy compared to patients continuing methotrexate.1 These results will be presented at the 2018 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago.
NORTH CHICAGO, Ill., Oct. 22, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive results from U-ACHIEVE, an ongoing Phase 2b/3 dose-ranging study evaluating upadacitinib, an investigational JAK1-selective inhibitor, for induction and maintenance therapy in adult patients with moderately to severely active ulcerative colitis.1 After 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints.1 These clinical data, in addition to patient-reported outcomes data from the study, are being presented at United European Gastroenterology (UEG) Week 2018 in Vienna, Austria. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
NORTH CHICAGO, Ill., Oct. 17, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). If the sNDA is approved, the use of IMBRUVICA with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL. IMBRUVICA is currently FDA-approved to treat adults with CLL/SLL as a single-agent for all lines of therapy and in combination with bendamustine and rituximab (BR).1 IMBRUVICA is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
NORTH CHICAGO, Ill., Oct. 16, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present new data across investigational medicines and HUMIRA® (adalimumab) at United European Gastroenterology (UEG) Week 2018 from October 20-24 in Vienna. These include four oral presentations of new data evaluating upadacitinib in both Crohn's disease and ulcerative colitis and risankizumab in Crohn's disease, as well as two poster presentations of HUMIRA data in Crohn's disease.
NORTH CHICAGO, Ill., Oct. 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present data from multiple studies of upadacitinib, an investigational oral JAK1-selective inhibitor, and HUMIRA® (adalimumab) at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting, October 19-24, in Chicago.
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