Tag Archives: ankylosing spondylitis

October, 2018

24 October
Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet

CHICAGO–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced that detailed results from two clinical trials evaluating filgotinib, an investigational, selective JAK1 inhibitor, for the treatment of psoriatic arthritis and ankylosing spondylitis were both published in The Lancet. The publication of the Phase 2 EQUATOR …
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28 June
Lilly’s Taltz Met Primary and Major Secondary Endpoints in Late-Stage Ankylosing Spondylitis Trial

INDIANAPOLIS, June 28, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today that Taltz® (ixekizumab) met the primary and major secondary endpoints in COAST-W, a Phase 3 study evaluating the safety and efficacy of Taltz for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the first …
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23 October
Janssen’s Simponi Aria Receives FDA Approval for Psoriatic Arthritis and Ankylosing Spondylitis

Horsham, Pa., October 20, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Today’s …
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26 April
Samsung Bioepis’ Biosimilar Version of Remicade Receives FDA Approval

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved RENFLEXIS™ (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, RENFLEXIS™ is indicated for reducing signs and symptoms in patients with adult and …
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19 October
Pfizer Announces the US Availability of Biosimilar Inflectra

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the company will begin shipment of INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE®1 (infliximab) to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be …
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26 September
FDA Approves Amgen’s Humira Biosimilar for Treatment of Seven Inflammatory Diseases

THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment …
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19 September
Pfizer’s Remicade Biosimilar Candidate Succeeds in Late-Stage Study

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced the confirmatory study (REFLECTIONS B537-02) evaluating the efficacy, safety, and immunogenicity of PF-06438179 (infliximab-Pfizer) compared to Remicade® (infliximab) met its primary endpoint. The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology …
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31 August
FDA Approves Sandoz’s Erelzi, a Biosimilar to Enbrel

Holzkirchen, August 30, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) approved Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) …
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10 February
FDA Panel Backs Pfizer and Celltrion’s Proposed Biosimilar Infliximab

Pfizer Inc. commends today’s recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three. Celltrion’s proposed biosimilar infliximab, to which Pfizer holds exclusive U.S. commercialization rights, is the …
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1 April
Biogen’s Biosimilar Version of Remicade Accepted for Review by EMA

Biogen recently announced that European health regulators have accepted its biosimilar version of Remicade for review. The company said that the Marketing Authorization Application (MAA) for SB2, its biosimilar infliximab candidate using Remicade as a reference product, has been validated for review by the European Medicines Agency (EMA). The application …
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