Originally published by our sister publication Gastroenterology & Endoscopy News

The FDA has approved risankizumab (Skyrizi, AbbVie), an interleukin-23 inhibitor, for patients with moderate to severe ulcerative colitis. It is the first IL-23 inhibitor approved for treating both moderate to severe ulcerative colitis and moderate to severe Crohn’s disease.

The approval follows positive results from two multicenter randomized, double-blind, controlled, phase 3 clinical trials: the 12-week INSPIRE induction trial and 52-week COMMAND maintenance trial. Both trials achieved the primary end point of clinical remission and secondary end point of improved endoscopic outcomes.

The INSPIRE trial evaluated the efficacy and safety of 1,200 mg of IV risankizumab administered as an induction dose every four weeks for 12 weeks in patients with moderately to severely active UC. In the COMMAND trial, patients who responded to IV risankizumab treatment in the INSPIRE study were randomly assigned to receive either 180 or 360 mg of risankizumab for an additional 52 weeks or to withdraw from treatment.

Risankizumab is administered in two phases: a 12-week induction period with three 1,200-mg doses every four weeks, followed by ongoing treatment of either 180 or 360 mg every eight weeks. Treatment can be maintained at home using an on-body injector.

“When treating patients with ulcerative colitis, it’s important to prioritize both early and sustained clinical remission as well as endoscopic improvement,” noted Edward Loftus Jr., MD, a professor of gastroenterology at Mayo Clinic in Rochester, Minn., in an AbbVie press release. “This approval for [risankizumab] is an important step toward addressing these treatment goals.”

—Norah Chinn

Based on a press release from AbbVie.