Jyseleca (filgotinib) - CHMP positive opinion - ulcerative colitis

17 September 2021: The CHMP has adopted a positive opinion for Jyseleca (filgotinib) for the treatment of ulcerative colitis.

The final indication is:

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.

The prevision of  EC decision is between 15-Oct to 12-November.