Posted by Michael Wonder on 30 Nov 2021
AbbVie submits application for risankizumab (Skyrizi) in moderate to severe Crohn's disease to European Medicines Agency
30 November 2021 - Submission supported by three pivotal Phase 3 trials in which risankizumab demonstrated significant improvements in clinical remission and endoscopic response as both induction and maintenance therapy.
AbbVie today announced it has submitted an application to the EMA seeking approval for risankizumab (Skyrizi, 600 mg intravenous induction and 360 mg subcutaneous maintenance therapy), an interleukin-23 inhibitor, for the treatment of patients 16 years and older with moderate to severe active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
The submission is supported by three pivotal Phase 3 trials, ADVANCE, MOTIVATE and FORTIFY.
