U.S. & E.U. Differ on Filgotinib for RA

Safety profiles were consistent in the FINCH and DARWIN trials when filgotinib was administered with methotrexate or as monotherapy. Serious infections and herpes zoster rates for filgotinib were similar to those for adalimumab and methotrexate in RA patients. Major adverse cardiac events and venous thromboembolism were infrequently reported.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

Gilead Sciences Inc. News release: Gilead receives complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis. 2020 Aug 18.
Taylor NP. FDA rejects Gilead’s would-be blockbuster filgotinib over toxicity concerns. Fierce BioTech. 2020 Aug 19.
Gilead Sciences Inc. News release: Gilead and Galapagos announce positive European CHMP opinion for Jyseleca (filgotinib) for the treatment of adults with moderate to severe rheumatoid arthritis. 2020 Jul 24.

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