AbbVie Submits Regulatory Application to FDA for SKYRIZI Subcutaneous

 

• Submission supported by data from Phase 3 pivotal AFFIRM study
• If approved, adult Crohn's disease patients will have an additional option for induction of risankizumab-rzaa which is already approved for intravenous (IV) induction

https://news.abbvie.com/2026-04-27-AbbVie-Submits-Regulatory-Application-to-FDA-for-SKYRIZI-R-risankizumab-rzaa-Subcutaneous-Induction-for-Adults-with-Moderately-to-Severely-Active-Crohns-Disease