AbbVie (NYSE: ABBV) submitted an application to the U.S. Food and Drug Administration seeking approval for subcutaneous induction dosing of SKYRIZI (risankizumab-rzaa) to treat adults with moderately to severely active Crohn's disease, the company announced.

The application is supported by data from the Phase 3 AFFIRM study, which evaluated the efficacy and safety of subcutaneous risankizumab as an induction treatment in 289 adult patients with the condition. The study randomized participants in a 2:1 ratio to receive either subcutaneous risankizumab or placebo, with 65% of participants having previously failed advanced therapies for Crohn's disease treatment.

SKYRIZI became the first interleukin-23 specific inhibitor approved by the FDA in 2022 for treating adults with moderately to severely active Crohn's disease, currently administered through intravenous infusion for induction. If approved, the subcutaneous option would provide patients with a choice between subcutaneous injection or intravenous infusion for induction, followed by subcutaneous maintenance dosing every eight weeks.

The AFFIRM study's co-primary endpoints were achievement of CDAI Clinical Remission and endoscopic response at week 12. AbbVie anticipates FDA approval for the new dosing regimen later this year.

Crohn's disease affects approximately 1 million Americans and is characterized by chronic inflammation within the gastrointestinal tract, most commonly between the small intestine and colon. The condition causes persistent diarrhea and abdominal pain and is progressive, potentially leading to complications requiring surgery.

SKYRIZI is currently approved by the FDA and European Medicines Agency for treating plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.