Posted by Michael Wonder on 02 Jun 2024
AbbVie receives positive CHMP opinion for risankizumab (Skyrizi) for the treatment of adults with moderately to severely active ulcerative colitis
31 May 2024 - The positive opinion is based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of risankizumab in adults with moderately to severely active ulcerative colitis.
AbbVie today announced that the EMA's CHMP adopted a positive opinion recommending the approval of risankizumab (Skyrizi) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy.
