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Rheumatoid Arthritis

FDA Approves Pfizer’s Biosimilar Abrilada (adalimumab-afzb) for Multiple Inflammatory Conditions

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.2 For full details …

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Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in Late-Stage Rheumatoid Arthritis Studies

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of moderately-to-severely active rheumatoid …

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Novartis Positive 52-week PREVENT Data Confirm Cosentyx Efficacy in Addressing Entire axSpA Spectrum

Basel, October 02, 2019 – Novartis, a leader in rheumatology and immuno-dermatology, today announced additional positive data from the PREVENT trial, evaluating the efficacy and safety of Cosentyx® (secukinumab) in patients with non-radiographic axial spondyloarthritis (nr-axSpA). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 52, showing a significant …

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Novartis’ Cosentyx Met the Primary Endpoint in its Phase 3 Trial in Patients with Non-Radiographic Axial Spondyloarthritis

Basel, September 17, 2019 – Novartis, a leader reimagining rheumatology and immuno-dermatology, today announced positive new data from the PREVENT trial evaluating the efficacy and safety of Cosentyx® (secukinumab) in patients with nr-axSpA (non-radiographic axial spondyloarthritis). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 16, showing a significant …

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FDA Approves Lilly’s Taltz for the Treatment of Patients with Active Ankylosing Spondylitis

INDIANAPOLIS, Aug. 26, 2019 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the third indication for Taltz, which was first approved …

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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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