The FDA has approved risankizumab for Crohn’s disease

Inflammation caused by Crohn’s disease can affect different parts of the digestive tract from person to person.

Many patients with Crohn’s disease can lead a normal life with treatment. Photo: Shutterstock.

Through a statement, the pharmaceutical ABBVIE confirmed that the US Food and Drug Administration (FDA) has approved risankizumab-rzaa for a third indication: treatment of Crohn’s disease moderately to highly active in adults, making it the first specific monoclonal anti-interleukin 23 (IL-23) antibody shown 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 supportive clinical trial (FORTIFY).

The results of the three studies were presented at the annual scientific meeting of the American College of Gastroenterology (ACG) in 2021, “in both induction and maintenance clinical trials significantly more elderly patients had little or no symptoms and a reduction, a significant reduction in visible signs of intestinal inflammation compared to placebo “, Marla Dubinski, gastroenterologist at Mount Sinai Health System and co-director of the IBD Center in Mount Sinai, in a press release from ABBVIE.

“This approval provides health professionals with the much-needed additional option to treat the destructive symptoms of Crohn’s diseasesaid Dubinski.

For the treatment of Crohn’s diseaseRisankizumab is given as a 600 mg intravenous infusion over at least 1 hour at weeks 0, 4 and 8, followed by a single subcutaneous injection of 360 mg 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.

Source: Press release.