AbbVie Wins FDA Approval for Pediatric Skyrizi, First IL-23 for Kids

The U.S. Food and Drug Administration (FDA) approved AbbVie's Skyrizi (risankizumab-rzaa) for children aged 6 and older. This approval covers pediatric patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis.

Skyrizi is now the first IL-23 inhibitor available in the U.S. for this demographic. The FDA based its decision on results from the Phase 3 OptIMMize clinical trial program.

This label expansion targets a market where approximately 20,000 U.S. children under 10 are diagnosed with psoriasis annually. Skyrizi remains a primary revenue driver for AbbVie.

The approval includes a new 55 mg prefilled syringe. This delivery method supports weight-based dosing for younger patients.