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Successful completion of End-of-Phase 2 FDA and EMA consultations in rheumatoid arthritis (RA)

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Additional Information

Additional Relevant Details – Galapagos NV (Euronext & NASDAQ: GLPG) reports the successful completion of the discussions with the regulatory authorities in the US and Europe and discloses the doses for the FINCH global Phase 3 program with filgotinib in RA. The FINCH program will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily, globally addressing a broad RA patient population, with dosing expected to begin in Q3’16. The FINCH Phase 3 program will also contain a dedicated male patient testicular safety study.
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Occurred on:
May 24, 2016
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Related Keywords Rheumatoid Arthritis, Ra, End-of-phase 2, Ema Consultations, Filgotinib, Finch Program