Rheumatoid Arthritis

Rinvoq Meets Primary and Key Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis

NORTH CHICAGO, Ill., Feb. 5, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-PsA 1 clinical trial. In this study, both doses of RINVOQTM (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week …

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Horizon Announces Topline Data Demonstrating Methotrexate with Krystexxa Significantly Improves Response Rate in Patients with Gout

DUBLIN–(BUSINESS WIRE)–Horizon Therapeutics plc (Nasdaq: HZNP) announced today topline results from its MIRROR open-label study in which methotrexate with KRYSTEXXA® (pegloticase injection) provided an increased durability of response for people living with chronic gout refractory to conventional therapies – also known as uncontrolled gout. Data from the Methotrexate to Increase Response Rates in Patients …

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Gilead and Eisai Partner in Japan for the Co-Promotion of Investigational RA Therapy Filgotinib, Pending Regulatory Approval

FOSTER CITY, Calif. & TOKYO–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Eisai Co., Ltd. (Tokyo, Japan) announced today that Gilead Sciences K.K. (Tokyo, Japan) and Eisai have entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for …

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FDA Approves Amgen’s Avsola (infliximab-axxq), for the Same Indications as Remicade

THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in …

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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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