The FDA has approved Skyrizi (risankizumab-rzaa), the first and only IL-23 inhibitor in the U.S., to treat children ages 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. The approval also includes a new 55-milligram pre-filled syringe for weight-based dosing in patients weighing less than 40 kilograms.
The pediatric plaque psoriasis indication was supported by data from the phase 3 OptIMMize psoriasis clinical trial program, according to a June 26 news release. At Week 16 of the trial program, risankizumab demonstrated clinically meaningful improvements in static Physician’s Global Assessment and Psoriasis Area and Severity Index responses, with responses maintained through continued treatment. The safety profile observed in pediatric plaque psoriasis patients was consistent with the established safety profile in adults.
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