FDA Appropves Risankizumab For Crohn’s Disease

The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (SKYRIZI) for the treatment of adults with moderately to severly active Crohn’s disease.

The approval, awarded to AbbVie, represents the first and only specific interleukin-23 (IL-23) inhibitor for this patient population.

The approval is based on a pair of induction trials calledADVANCE and MOTIVATE, as well as a maintenance trial dubbed fortify.

In these trials, the treatment resulted in significant improvements endoscopic response (defined as a decrease of greater than 50% from the baseline Simple Endoscopic Score in CD [SES-CD or patients with isolated ileal disease and SES-CD of 4, at least a 2-point reduction from baseline and clinical remission, defined as a Crohn's Disease Activity Index (CDAI) of less than 150, compared to placebo.

The dosing regimen for the treatment is 600 mg administered by intravenous infusion over at least one hour at week 0, week 4, and week 8. This is followed by 360 mg self-administered by subcutaneous injection with an on-body injector at week 12, and every 8 weeks after. A 180 mg self-administered subcutaneous maintenance dose option is currently under review by the FDA.

"In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo," said Marla Dubinsky, MD, chief, division of pediatric gastroenterology for the Mount Sinai Health System, co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai, in a statement. "This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn's disease."