Posted by Michael Wonder on 28 Aug 2023
AbbVie submits regulatory applications to FDA and EMA for risankizumab (Skyrizi) in ulcerative colitis
29 August 2023 - Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment.
AbbVie today announced that it has submitted applications for a new indication to the US FDA and the EMA for risankizumab (Skyrizi, 1200 mg intravenous [induction dose] and 180 mg and 360 mg subcutaneous [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis.
