ABBV · News · 20260827N

Regulatory Approval Milestones

AbbVie Inc. · 2026-08-27 · Importance 34 · Surprise 42 · In source text

AbbVie submitted an application to the European Medicines Agency on August 27, 2026, seeking approval for subcutaneous induction of SKYRIZI (risankizumab) in adults with moderately to severely active Crohn’s disease. The application is supported by positive Phase 3 AFFIRM study data and would add a subcutaneous induction option to the existing intravenous induction and subcutaneous maintenance regimen. If approved, patients could select subcutaneous or intravenous induction before continuing with subcutaneous maintenance every eight weeks, potentially expanding SKYRIZI’s European Crohn’s disease use.

Key facts

• AbbVie Inc. submitted an application to the European Medicines Agency (EMA) seeking approval for SKYRIZI (risankizumab) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease on Aug. 27, 2026. source
• If approved by the EMA, adult Crohn's disease patients could choose between subcutaneous (SC) injection or intravenous (IV) infusion for induction of SKYRIZI, followed by SC maintenance every eight weeks. source
• The submission for SKYRIZI SC induction is supported by data from the Phase 3 pivotal AFFIRM study. source
• AbbVie Inc.'s SKYRIZI (risankizumab) was already approved for intravenous (IV) induction prior to this EMA submission. source

Impact estimates