Jyseleca (filgotinib) : EC Decision for the treatment of ulcerative colitis

Following the positive CHMP Opinion adopted on 16-Sept, Gilead has received the EC Decision (12-Nov-2021 adoption of Commission Decision)  granting approval for Jyseleca (filgotinib) for the treatment of ulcerative colitis.

The final indication is:

Ulcerative colitis

Jyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent