Posted by Michael Wonder on 20 Sep 2021
AbbVie submits regulatory application to FDA for risankizumab-rzaa (Skyrizi) for the treatment of patients 16 years and older with moderate to severe Crohn's disease
20 September 2021 - In three pivotal Phase 3 trials, risankizumab-rzaa demonstrated significant improvements in clinical remission and endoscopic response as both induction and maintenance therapy.
AbbVie today announced that it has submitted an application to the U.S. FDA seeking approval for risankizumab-rzaa (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 Crohn's disease.
The submission is supported by safety and efficacy data from three Phase 3 studies – ADVANCE, MOTIVATE and FORTIFY.
