Rheumatoid Arthritis

AbbVie Submits Regulatory Application to FDA for Rinvoq for Treatment of Adults with Active Ankylosing Spondylitis

NORTH CHICAGO, Ill., Aug. 25, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQ™ (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult patients with active …

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FDA Rejects Gilead’s Filgotinib for Treatment of Rheumatoid Arthritis Over Safety Concerns

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA). The FDA has requested data from …

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Mylan and Fujifilm Kyowa Kirin Biologics Announce that the FDA Approved of Hulio, a Biosimilar to Humira

HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic …

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FDA Approves Novartis’ Cosentyx for Treatment of Active Non-Radiographic Axial Spondyloarthritis

Basel, June 17, 2020 — Novartis, a leader in rheumatology and immuno-dermatology, today announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum9. “The results from the PREVENT trial …

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New Research Shows Rheumatologists See Telemedicine, Advanced Practice Providers as Keys to Managing Growing Demand for Care

DUBLIN, Ohio, June 16, 2020 /PRNewswire/ — Faced with a decreasing number of healthcare providers and growing patient volume as the Baby Boomer generation ages, surveyed rheumatologists said they plan to hire more advanced practice providers (APPs), expand patient care with telemedicine and invest in technology to manage the increased …

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Novel Antibody Drug Conjugate ABBV-3373 Shows Improvement in Disease Activity in Phase 2a Study in Rheumatoid Arthritis

NORTH CHICAGO, Ill., June 10, 2020 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new data from a Phase 2a study of ABBV-3373, an investigational anti-tumor necrosis factor (TNF) Glucocorticoid Receptor Modulator (GRM) steroid antibody drug conjugate (ADC), in adult patients with moderate to severe rheumatoid arthritis.1 The primary endpoint was …

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Filgotinib Demonstrates Durable Efficacy and Consistent Safety Profile at 52 Weeks in FINCH 1 and 3 Studies in Rheumatoid Arthritis

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today announced Week 52 results from the Phase 3 FINCH 1 and FINCH 3 studies of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately to severely active rheumatoid arthritis …

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Lilly’s Taltz is the First IL-17A Antagonist to Receive FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis

INDIANAPOLIS, June 1, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection 80 mg/mL for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. Another first-in-class milestone for the treatment, …

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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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