AbbVie (NYSE: ABBV) has submitted an application to the European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab) subcutaneous (SC) induction in adults with moderately to severely active Crohn's disease (CD), extending a regulatory push that began with a US FDA filing in April 2026. If approved, patients in the EU would gain the option to receive their induction doses via SC injection rather than the intravenous (IV) infusion currently required under the existing EU marketing authorization.
The filing is supported by positive Phase III data from the AFFIRM study (NCT06063967), a randomized, placebo-controlled, double-blind trial enrolling 289 adults with moderately to severely active CD. At week 12, significantly greater proportions of patients receiving risankizumab SC achieved both co-primary endpoints — Crohn's Disease Activity Index (CDAI) clinical remission (CDAI < 150) and endoscopic response — compared with placebo (55% vs. 30% and 44% vs. 14%, respectively; both p<0.0001). The trial enrolled a predominantly treatment-refractory population, with 65% having previously failed at least one advanced therapy. The safety profile was consistent with risankizumab's established profile in CD, with no new safety signals identified.
Risankizumab selectively blocks IL-23 by binding to its p19 subunit, inhibiting downstream Th17-driven intestinal inflammation. The molecule has been approved in the EU for IV induction and SC maintenance in CD since 2022, when it became the first specific IL-23 inhibitor authorized for the indication in the EU.