AbbVie Seeks EMA Approval for Subcutaneous Skyrizi in Crohn's Treatment

The regulatory request follows positive results from the Phase 3 AFFIRM study, which measured the safety and efficacy of the interleukin-23 inhibitor in patients with and without histories of prior treatment failure. The trial, which randomized 289 participants, focused on achieving clinical remission and endoscopic response by the 12-week mark.

"This submission builds on the growing body of evidence supporting Skyrizi and reflects our efforts to advance treatment approaches that may help patients achieve important clinical and endoscopic outcomes," said Roopal Thakkar, AbbVie’s executive vice president of research and development. If the EMA grants approval, patients may gain the ability to switch between subcutaneous injections and intravenous infusions for induction, followed by standard maintenance doses every eight weeks. Since its initial authorization in 2022, Skyrizi has served as a key option for those who have not responded to conventional or biologic therapies for the progressive condition.