FDA Approves Risankizumab for Ulcerative Colitis

The U.S. Food and Drug Administration (FDA) on June 18 approved risankizumab for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis (UC) and moderate to severe Crohn's disease.

Miguel Regueiro, MD, professor of medicine and director of the Digestive Disease Center at Cleveland Clinic in Cleveland, Ohio, observed that efficacy and safety data in the INSPIRE 12-week induction study and the COMMAND 52-week maintenance trial of risankizumab for UC “were quite good, especially in patients who were naive to advanced therapies. The endoscopic improvement was impressive.”  

In the 12-week induction period for risankizumab for UC, patients receive three 1200 mg doses delivered every 4 weeks. This is followed by maintenance therapy of 180 mg or 360 mg delivered every 8 weeks. Maintenance treatment can be delivered by patients at home using device that adheres to the body and takes about 5 minutes to deliver the medication following preparation.

"With the approval of risankizumab, providers now have another incredibly safe, effective, durable, and convenient therapy for patients with ulcerative colitis," said Raymond Cross, MD, of Mercy Medical Center in Baltimore, Maryland. "Positioning of risankizumab in practice will likely depend on payers and patient preferences."

More than 1 million people in the US are living with ulcerative colitis, the US has one of the largest populations affected by this disease and the numbers are continuing to rise. “This represents another great option for our UC patients,” Dr Regueiro said.

Rebecca Mashaw

Reference:

U.S. FDA approves SKYRIZI® (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie's portfolio across inflammatory bowel disease. Press release. AbbVie; June 18, 2024. Accessed June 20, 2024. https://news.abbvie.com/2024-06-18-U-S-FDA-Approves-SKYRIZI-R-risankizumab-rzaa-for-Ulcerative-Colitis,-Expanding-AbbVies-Portfolio-Across-Inflammatory-Bowel-Disease