Research & Development
AbbVie's SKYRIZI receives US FDA approval to treat adults with moderately to severely active Crohn's disease
20 June 2022 -

United States-based AbbVie (NYSE: ABBV) announced on Friday that it has received approval from the United States Food and Drug Administration (FDA) for its SKYRIZI (risankizumab-rzaa) as the first and only specific interleukin-23 (IL-23) inhibitor intended to treat adults with moderately to severely active Crohn's disease (CD).

During two induction and one maintenance clinical trials, the product showcased significant improvements in endoscopic response (defined as a decrease of greater than 50% from the baseline Simple Endoscopic Score in CD [SES-CD] or for patients with isolated ileal disease and SES-CD of four, at least a two-point reduction from baseline) and clinical remission (defined as a Crohn's Disease Activity Index [CDAI] of less than 150), compared to placebo, as both an induction and maintenance therapy.

Marla Dubinsky, M.D., chief, division of paediatric gastroenterology for the Mount Sinai Health System, co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai, said, '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. This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn's disease.'