FDA Approves Risankizumab (Skyrizi) for Crohn’s Disease

Megan Brooks

June 17, 2022

The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication — treatment of moderately to severely active Crohn’s disease in adults — making it the first specific anti-interleukin 23 (IL-23) monoclonal antibody indicated for Crohn’s disease.

The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).

Results of the three studies were presented at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting and reported by Medscape Medical News at that time.

“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,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and co-director of the IBD Center at Mount Sinai, said in a news release from AbbVie.

“This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dubinsky said.

For the treatment of Crohn’s disease, risankizumab is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.

Risankizumab is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.

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