NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with methotrexate. Results showed that after 14 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)*** versus continuing prior stable methotrexate therapy.1 Both doses also achieved all ranked and all key secondary endpoints.1 Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
NORTH CHICAGO, Ill., Dec. 12, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research and development based global biopharmaceutical company, today announced the first presentation of efficacy and safety results from MURANO, an international, multicenter, open-label, randomized Phase 3 study of VENCLEXTA™/VENCLYXTO™ (venetoclax) in combination with Rituxan® (rituximab) compared with bendamustine in combination with Rituxan in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL).
NORTH CHICAGO, Ill., Dec. 11, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new data on the biologic and cellular mechanisms of IMBRUVICA® (ibrutinib) in patients with chronic graft-versus-host disease (cGVHD), a potentially life-threatening consequence of an allogeneic stem cell or bone marrow transplant.1 New results showed ibrutinib selectively inhibited pre-germinal center B cells and follicular helper T cells (Tfh) that are believed to play a critical role in treating cGVHD. In addition, the data also showed that ibrutinib preserved immune memory and Th1 T cells, which suggests the potential for additional treatment benefit. These results were observed in a Phase 1b/2 trial (PCYC-1129).
NORTH CHICAGO, Ill., Dec. 9, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced pooled analysis results of the longest follow-up data to date in Bruton's tyrosine kinase (BTK) inhibition for relapsed/refractory (R/R) mantle cell lymphoma (MCL) patients treated with IMBRUVICA® (ibrutinib). The analysis found that, at three years, 45 percent of patients were able to achieve overall survival (OS) and 26 percent had disease progression-free survival (PFS). The pooled analysis also found that patients who were treated with ibrutinib earlier, after their first relapse/progression, experienced higher rates of OS and PFS.1 The analysis is comprised of data from a total of 370 patients in three different clinical trials: SPARK, RAY and PCYC-1104, and one ongoing Phase 3b extension study, CAN3001, which is eligible to patients who continue to benefit from ibrutinib therapy upon completing a previous ibrutinib clinical trial.2 MCL is an aggressive B-cell malignancy in which most patients relapse after their first line of therapy and receive a poor prognosis.3
NORTH CHICAGO, Ill., Dec. 9, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced new three-year follow-up data from the RESONATE™-2 study (PCYC-1115/1116), which found that previously-untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients reported sustained improvements in measures of well-being with IMBRUVICA® (ibrutinib) versus chemotherapy with chlorambucil. These new data provide the longest quality of life follow up for ibrutinib to date using patient-reported outcomes (PRO). Patients reported their quality of life outcomes for fatigue, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. At 30 months, ibrutinib was also associated with a greater progression-free survival (PFS) rate of 85 percent versus chlorambucil, which had a PFS rate of 28 percent.
NORTH CHICAGO, Ill., Dec. 5, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the Phase 3 iNNOVATE (PCYC-1127) trial evaluating IMBRUVICA® (ibrutinib) in combination with rituximab in patients with treatment-naïve and previously-treated Waldenström's macroglobulinemia (WM) successfully met its primary endpoint and demonstrated improvement of progression-free survival (PFS) compared to rituximab alone. The Independent Data Monitoring Committee (IDMC) recommended that the study be unblinded based on the positive outcome from the pre-specified interim analysis data. IMBRUVICA, a first-in-class Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
NORTH CHICAGO, Ill., Dec. 4, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from IMMhance, the fourth pivotal Phase 3 clinical trial evaluating risankizumab (150 mg) for the treatment of patients with moderate to severe plaque psoriasis.1 There were two phases in this study. Results from the first phase showed that after 16 weeks of treatment, risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) versus placebo.1 In the second phase of this study, the primary endpoint of sPGA 0/1 at week 52 (one year) was also met.1 The second phase (week 28 through 104) is evaluating the efficacy and safety of continuous therapy with risankizumab versus randomized withdrawal. Subsequently, retreatment is also being evaluated in this ongoing study. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established. Results from IMMhance through week 16 were presented during an oral presentation at the 8th International Congress of Psoriasis from Gene to Clinic meeting in London on December 2nd.
NORTH CHICAGO, Ill., Nov. 21, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the American Society of Hematology (ASH) has accepted data from the Phase 3 MURANO study evaluating venetoclax tablets in combination with rituximab in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), as an oral, late-breaking presentation during the upcoming 59th ASH Annual Meeting & Exposition, December 9-12, in Atlanta, GA. The abstract is one of six late-breaking abstracts accepted for presentation at the meeting.
NORTH CHICAGO, Ill., Nov. 1, 2017 /PRNewswire/ -- AbbVie (NYSE:ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced detailed results from two replicate Phase 3 extension studies evaluating the long-term efficacy and safety of elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being evaluated for the management of endometriosis with associated pain. In the extension studies, elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain and non-menstrual pelvic pain in women through the 12-month treatment period. The safety and tolerability of elagolix was consistent with the anticipated effects of reduced estradiol levels and no new safety concerns were identified with elagolix use for the 12-month treatment period1. These results, and other additional abstracts, were presented at the American Society for Reproductive Medicine Scientific Congress & Expo (ASRM) in San Antonio.
NORTH CHICAGO, Ill., Oct. 27, 2017 /PRNewswire/ -- AbbVie (NYSE:ABBV), a research and development based global biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated for the management of endometriosis with associated pain. The FDA grants priority review to medicines that it determines have potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease1. AbbVie expects the Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review will be in Q2 2018.
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