European regulator to review filgotinib for ulcerative colitis

3 November 2020

A submission for European marketing authorization for filgotinib in ulcerative colitis (UC) has been validated, and will be reviewed by the European Medicines Agency.

US biotech major Gilead Sciences (Nasdaq: GILD) and its co-developer, Belgium-based Galapagos (Euronext: GLPG), are developing the oral JAK-1 blocker in multiple indications.

The submission in UC is based on results from the Phase IIb/III SELECTION trial, which achieved all primary endpoints, inducing clinical remission at week 10, at the higher 200mg dose.

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