AbbVie Submits EMA Application for Skyrizi Subcutaneous Induction in Moderate to Severe Crohn’s Disease – AbbVie

 AbbVie announced that it has 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 (CD).

The application to the EMA is supported by the recently shared positive data from the Phase 3 AFFIRM study1 (NCT06063967), which evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, in those with and without prior advanced therapy failure.

“As treatment goals in Crohn’s disease continue to evolve, it is important to provide therapies that can deliver meaningful outcomes from the earliest stages of treatment through long-term disease management. This submission builds on the growing body of evidence supporting Skyrizi and reflects our efforts to advancing treatment approaches that may help patients achieve important clinical and endoscopic outcomes.” – Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer, AbbVie.

In 2022, Skyrizi became the first specific IL-23 inhibitor approved for the treatment of Crohn’s disease in the European Union (EU) to treat adults with moderately to severely active Crohn’s disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. If approved, patients with moderately to severely active CD would have the option to receive their Skyrizi induction doses via SC injection or through IV infusion and then continue subcutaneous maintenance doses every eight weeks.