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Rheumatoid Arthritis

FDA Approves AbbVie’s Oral JAK Inhibitor Rinvoq for the Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Aug. 16, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ™ (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have …

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FDA Approves Samsung Bioepis’ Hadlima, a Biosimilar Referencing Humira

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the …

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FDA Approves Samsung Bioepis’ Eticovo, a Biosimilar to Enbrel

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved ETICOVO™ (etanercept-ykro), a biosimilar referencing ENBREL® (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO™ is Samsung Bioepis’ second …

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Lilly Announces Positive Top-Line Results from its Phase 3 Study Evaluating Taltz in Non-Radiographic Axial Spondyloarthritis

INDIANAPOLIS, April 22, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and all major secondary endpoints in COAST-X, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. …

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Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in Phase 3 Rheumatoid Arthritis Study

OSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24 results of FINCH 1, an ongoing, randomized, double-blind, placebo- and active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid …

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FDA Grants Priority Review to AbbVie’s Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is …

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Mallinckrodt Provides Update on Phase 4 Data H.P. Acthar Gel Clinical Trial in Rheumatoid Arthritis Patients

STAINES-UPON-THAMES, United Kingdom, Feb. 5, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, has completed the open-label phase of the ongoing Phase 4, multicenter study assessing the efficacy and safety of H.P. Acthar® Gel in patients with persistently active rheumatoid arthritis (RA) who were previously …

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Amgen and Allergan Announce Positive Top-Line Results from Phase 1/Phase 3 Study of ABP 798, Biosimilar Candidate to Rituximab

THOUSAND OAKS, Calif., Jan. 24, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc.(NYSE:AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis. The results demonstrate that the study …

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AbbVie Submits Applications to the FDA and EMA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

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 …

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Amgen Submits BLA to the FDA for ABP 710, a Biosimilar Candidate to Infliximab

THOUSAND OAKS, Calif., Dec. 17, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab). “At Amgen, we have spent nearly four decades developing, manufacturing and producing transformative medicines. We’re leveraging our deep expertise and …

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