On August 27, 2026, AbbVie announced that it 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. This EMA submission follows AbbVie’s FDA submission for the same SKYRIZI® SC product in April of 2026.
AbbVie states that its application is supported by positive data from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active Crohn’s disease, in those with and without prior advanced therapy failure. If approved, adult Crohn’s disease patients would have an additional option for induction of risankizumab, which is already approved for intravenous induction, meaning patients with moderately to severely active Crohn’s disease would have the option to receive their SKYRIZI® induction doses via SC injection or through intravenous infusion, and then continue SC maintenance doses every eight weeks.
According to AbbVie, SKYRIZI® became the first specific IL-23 inhibitor approved for the treatment of Crohn’s disease in the European Union in 2022.