- The EMA submission seeks approval of subcutaneous Skyrizi induction for adults with moderately to severely active Crohn’s disease.
- If approved, European patients would be able to choose subcutaneous injection or IV infusion for Skyrizi induction, followed by subcutaneous maintenance dosing every eight weeks.
- The application is supported by the global Phase 3 AFFIRM trial, which evaluated subcutaneous risankizumab induction versus placebo.
Quotes
“This submission builds on the growing body of evidence supporting SKYRIZI and reflects our efforts to advancing treatment approaches that may help patients achieve important clinical and endoscopic outcomes.”