European Medicines Agency validates marketing application for filgotinib for the treatment of ulcerative colitis.- Gilead Sciences + Galapagos NV.

Gilead Sciences, Inc. and Galapagos NV announced that the application for a new indication to the approved license for filgotinib 200 mg, an oral JAK1 preferential inhibitor, has been validated and is now under evaluation by the European Medicines Agency (EMA). The proposed indication is for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. The EMA application is supported by data from the Phase IIb/III SELECTION study, which showed a statistically significantly higher proportion of patients treated with once-daily, oral, filgotinib 200 mg achieved clinical remission at week 10 and maintained remission at week 58 compared with placebo. Additionally, a statistically significantly higher proportion of patients treated with filgotinib 200 mg achieved endoscopic, histologic and six-month, corticosteroid-free remission at week 58 compared with placebo. The SELECTION trial results were presented at the virtual United European Gastroenterology Week (UEGW) 2020 Meeting last month..