Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan

Shots:

• The submission is based on P-IIb/III SELECTION study evaluating the efficacy and safety of filgotinib (200mg, qd) vs PBO in patients with mod. to sev. active UC who had an inadequate response or were intolerant to either conventional therapy or a biological agent
• Results: patients achieved clinical remission @10wks., maintained remission @ 58 wks. and no new safety risks were observed
• The applications have been submitted to EMA and MHRA for mod. to sev. active UC and are currently under review. Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the EU, Great Britain, and Japan for mod. to sev. active RA

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