Tag Archives: psoriatic arthritis

December, 2018

17 December
Lilly Announces Positive Top-Line Results for Taltz vs. Humira in Head-to-Head Superiority Study in Patients with Psoriatic Arthritis

INDIANAPOLIS, Dec. 17, 2018 /PRNewswire/ — Eli Lilly and Company(NYSE: LLY) announced today Taltz® (ixekizumab) met the primary and all major secondary endpoints in the Phase 3b/4 SPIRIT-H2H study, which evaluated the efficacy and safety of Taltz versus Humira®(adalimumab) in patients with active psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drug (DMARD)-naive. The SPIRIT-H2H …
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24 October
Study Finds Enbrel Monotherapy and Combination Therapy Both Superior to Methotrexate in Patients with Psoriatic Arthritis

THOUSAND OAKS, Calif., Oct. 24, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that positive results from the Phase 3 SEAM-PsA study comparing the efficacy of Enbrel® (etanercept) monotherapy and ENBREL plus methotrexate to methotrexate monotherapy in patients with psoriatic arthritis (PsA) were presented in a late-breaking poster session at the 2018 American College of Rheumatology (ACR)/Association of …
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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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31 May
Gilead and Galapagos Announce Positive Results with Filgotinib in Psoriatic Arthritis and Progression into Phase 3 Ulcerative Colitis Study

FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) announced that the randomized, placebo-controlled Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint of improvement in …
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15 December
Pfizer’s Xeljanz and Xeljanz XR Receive FDA Approval for the Treatment of Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response …
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4 December
Lilly’s Taltz Receives FDA Approval for the Treatment of Active Psoriatic Arthritis

INDIANAPOLIS, Dec. 1, 2017 /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 psoriatic arthritis (PsA).1 Taltz was first approved by the FDA in March 2016 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for …
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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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6 July
FDA Approves Bristol-Myers Squibb’s Orencia for Treatment of Active Psoriatic Arthritis

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis (PsA)1, a chronic2, inflammatory disease that can affect both the skin and musculoskeletal system.3 ORENCIA is approved and available in both intravenous and subcutaneous (SC) …
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16 June
Lilly’s Taltz Significantly Improves Disease Signs and Symptoms in Psoriatic Arthritis Patients with Inadequate Response or Intolerance to TNF Inhibitors

altz INDIANAPOLIS, June 15, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that patients with active psoriatic arthritis (PsA) who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors treated with Taltz® (ixekizumab) achieved significant improvement in signs and symptoms of …
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3 May
FDA Accepts for Review Pfizer’s sNDA for Xeljanz for Treatment of Patients with Active Psoriatic Arthritis

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A separate sNDA was also …
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