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Filgotinib FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 27, 2019.

FDA Approved: No
Generic name: filgotinib
Company: Gilead Sciences, Inc.
Treatment for: Rheumatoid Arthritis

Filgotinib is an oral, selective JAK1 inhibitor in development for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA).

Development timeline for filgotinib

Oct 12, 2020Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis
Aug 18, 2020Gilead Receives Complete Response Letter for Filgotinib for the Treatment of Moderately to Severely Active Rheumatoid Arthritis
May 20, 2020Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis
Dec 19, 2019Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment
Nov  9, 2019New Data on Filgotinib in Rheumatoid Arthritis (RA) Demonstrate Durable Efficacy and Safety Profile
Oct 10, 2019Gilead and Galapagos Announce Efficacy and Safety Results of Filgotinib Through 52 Weeks in FINCH 1 and FINCH 3 Studies in Rheumatoid Arthritis
Jul  1, 2019Gilead Announces Intent to Submit New Drug Application for Filgotinib to U.S. Food and Drug Administration This Year
Mar 28, 2019Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients
Oct 22, 2018Positive Trial Results with Filgotinib in Psoriatic Arthritis and Ankylosing Spondylitis Both Published in The Lancet
Sep  6, 2018Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint
May 30, 2018Gilead and Galapagos Announce Results With Filgotinib in the Phase 2 Equator Study in Psoriatic Arthritis and Progression Into Phase 3 for the Selection Study in Ulcerative Colitis

Further information

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