European Medicines Agency begins evaluation of marketing authorisation application for filgotinib as treatment of adults with moderately to severely active ulcerative colitis who have failed on or were intolerant to conventional or biologic therapy

The application is supported by data from the phase IIb/III SELECTION study, which demonstrated a statistically significant higher proportion of patients treated with filgotinib 200mg achieving clinical remission at week 10 and maintaining remission at week 58 compared to placebo

PharmaTimes