AbbVie seeks EMA approval for Skyrizi subcutaneous use in Crohn's

AbbVie (NYSE: ABBV) has submitted an application to the European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab) as a subcutaneous (SC) induction treatment for adults with moderately to severely active Crohn's disease.

The submission is supported by data from the Phase 3 AFFIRM study (NCT06063967), a randomized, placebo-controlled, double-blind trial evaluating the efficacy and safety of risankizumab SC as an induction treatment. The study enrolled 289 patients randomized in a 2:1 ratio to risankizumab SC or placebo, with co-primary endpoints of clinical remission and endoscopic response at week 12. Approximately 65% of patients had previously failed advanced therapies.

Skyrizi is already approved in the European Union for intravenous (IV) induction in adults with moderately to severely active Crohn's disease. If the EMA approves the new application, patients would have the option to receive induction doses via SC injection or IV infusion, followed by SC maintenance doses every eight weeks.

AbbVie states that Skyrizi became the first specific IL-23 inhibitor approved for Crohn's disease in the EU in 2022. The drug is currently approved by both the U.S. Food and Drug Administration and the EMA for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

"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," said Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer at AbbVie.

The most frequently reported adverse reactions associated with risankizumab include upper respiratory infections. Risankizumab is contraindicated in patients with hypersensitivity to the active substance and those with clinically important active infections, including active tuberculosis.

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