AbbVie (NYSE:ABBV) announced on Monday, April 27, 2026, that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for SKYRIZI (risankizumab-rzaa).
The application seeks approval for the IL-23 inhibitor as a subcutaneous (SC) induction therapy for adult patients with moderately to severely active Crohn's disease.
The submission is supported by positive data from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of SC induction.
Currently, SKYRIZI is indicated for Crohn’s disease using an initial intravenous (IV) induction phase followed by SC maintenance.
If approved, this new filing would offer clinicians and patients the flexibility to choose between SC and IV administration for the induction phase, potentially allowing for a fully subcutaneous treatment journey from the start of therapy.
Under the proposed dosing regimen, patients who achieve a clinical response during the SC induction phase would continue with the established SC maintenance dose of 360 mg every eight weeks.
This move aligns with AbbVie’s broader strategy to enhance patient convenience and treatment adherence in the competitive inflammatory bowel disease (IBD) market.