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This is the third approval for Skyrizi, which also treats psoriatic arthritis and plaque psoriasis.
The FDA has approved AbbVie’s Skyrizi (risankizumab-rzaa) as the first specific interleukin-23 (IL-23) inhibitor for the treatment of adults with moderate-to-severe Crohn’s disease.
The approval was based on two induction and one maintenance clinical trials, in which Skyrizi demonstrated significant improvements in endoscopic response and clinical remission compared with placebo, as both an induction and maintenance therapy.
“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 with placebo,” Marla Dubinsky, M.D., chief, division of pediatric gastroenterology for the Mount Sinai Health System, co-director of the Susan and Leonard Feinstein IBD Center at Mount Sinai, said in a press release. “This approval provides healthcare professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn's disease.”
In the 12-week induction studies, ADVANCE and MOTIVATE, a significantly proportion of patients treated with Skyrizi achieved endoscopic response and clinical remission compared to placebo. As early as week 4, clinical response and clinical remission were achieved in a significantly greater proportion of patients as compared with placebo.
In the 52-week maintenance trial, FORTIFY, a significantly greater proportion of patients achieved the co-primary endpoints of endoscopic response and clinical remission as compared with the placebo group after one year.
The dosing regimen is 600 mg administered by intravenous infusion over at least one hour at week 0, week 4, and week 8, followed by 360 mg self-administered by subcutaneous injection with an on-body injector at week 12, and every 8 weeks thereafter. A 180 mg self-administered subcutaneous maintenance dose option remains under review by the FDA.