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