AbbVie has asked European regulators to approve a subcutaneous version of SKYRIZI (risankizumab) for induction treatment in adults with moderately to severely active Crohn’s disease, potentially giving patients an alternative to the drug’s existing intravenous induction regimen.

 

The application submitted to the European Medicines Agency (EMA) is backed by results from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of subcutaneous risankizumab as an induction treatment in adults with moderately to severely active Crohn’s disease, including patients who had previously failed advanced therapies.

 

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

 

"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."

 

The AFFIRM trial enrolled 289 patients, with 65% having previously failed advanced therapies for Crohn’s disease. Patients were randomized in a 2:1 ratio to receive subcutaneous risankizumab or placebo.

 

The study’s co-primary endpoints were clinical remission, defined as a Crohn’s Disease Activity Index (CDAI) score below 150, and endoscopic response at week 12.

 

If approved, the new regimen would allow eligible European patients to receive SKYRIZI induction through a subcutaneous injection rather than intravenous infusion, before continuing with subcutaneous maintenance treatment every eight weeks.

 

SKYRIZI was approved in the European Union in 2022 for adults with moderately to severely active Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant to conventional or biologic therapy.

 

Crohn’s disease is a chronic inflammatory condition affecting the gastrointestinal tract. Symptoms can include persistent diarrhea and abdominal pain, while the progressive disease can lead to serious complications and, in some cases, surgery.