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BRIEF-Galapagos says completed end-of-Phase 2 FDA and EMA consultations in rheumatoid arthritis
May 24, 2016 / 8:31 PM / a year ago

BRIEF-Galapagos says completed end-of-Phase 2 FDA and EMA consultations in rheumatoid arthritis

May 24 (Reuters) - Galapagos Nv

* Successful completion of end-of-phase 2 FDA and EMA consultations in rheumatoid arthritis (RA)

* Completion of discussions with regulatory authorities in US and Europe

* Discloses doses for Finch global phase 3 program with filgotinib in RA

* Finch program will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily, with dosing expected to begin in Q3‘16

* Finch phase 3 program will also contain a dedicated male patient testicular safety study

* Gilead expects to initiate a phase 3 study with filgotinib in Crohn’s disease and a phase 2/3 study in ulcerative colitis in Q3 ‘16 Source text for Eikon: Further company coverage: (Bengaluru Newsroom: +1 646 223 8780)

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