AbbVie submitted a regulatory application to the European Medicines Agency (EMA) for a subcutaneous (SC) induction option for SKYRIZI (risankizumab). The treatment targets adults with moderately to severely active Crohn's disease.
This new delivery method provides an alternative to the currently approved intravenous (IV) induction. Positive data from the Phase 3 AFFIRM study supports the submission.
If approved, SKYRIZI would offer a complete subcutaneous regimen for both induction and maintenance doses every eight weeks. This development supports AbbVie's strategy to advance long-term disease management within its immunology franchise.