FDA Approves AbbVie's Skyrizi as First IL-23 Inhibitor for Pediatric Psoriatic Disease

FDA Approves AbbVie's Skyrizi as First IL-23 Inhibitor for Pediatric Psoriatic Disease

On June 26, 2026, the U.S. Food and Drug Administration (FDA) approved AbbVie’s blockbuster biologic Skyrizi (risankizumab-rzaa) for the treatment of children aged six years and older with moderate-to-severe plaque psoriasis (who are candidates for systemic therapy or phototherapy) or active psoriatic arthritis (PsA).

The approval represents a major milestone in pediatric immunology, making Skyrizi the first and only interleukin-23 (IL-23) inhibitor approved in the United States for pediatric patients weighing less than 40 kg with plaque psoriasis or active psoriatic arthritis.

Key Details of the Approval

• Weight-Based Dosing: To support pediatric administration, the FDA approved a new 55 mg pre-filled syringe (PFS) for children weighing less than 40 kg (approximately 88 lbs). For children weighing 40 kg or more, the standard adult 150 mg PFS and Pen are approved.
• Clinical Trial Data: The approval is supported by data from the Phase 3 OptIMMize clinical trial program (NCT04435600; NCT04862286). At Week 16, pediatric patients treated with risankizumab demonstrated clinically meaningful improvements in static Physician Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI) responses, which were maintained long-term. The pediatric PsA indication was supported by OptIMMize data and pharmacokinetic modeling based on well-controlled adult studies.¹
• Safety Profile: The safety profile of Skyrizi in pediatric patients was consistent with its established safety profile in adults, with upper respiratory infections, headache, and injection site reactions being the most common side effects.

Disease Burden and Market Impact

Psoriatic disease has a profound physical and psychological impact on pediatric patients. Approximately 30% of individuals with psoriasis develop symptoms before age 18. In the U.S. alone, an estimated 20,000 children under the age of ten are diagnosed with psoriasis annually, and 14,000 are affected by psoriatic arthritis.

By expanding its label to pediatric patients, AbbVie further solidifies Skyrizi's dominant position in the global immunology market, where it is already approved for adult plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

"We are proud that SKYRIZI is now the first and only IL-23 inhibitor approved in the U.S. for pediatric patients six years of age and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis. For families navigating these chronic conditions, expanding access to treatments with proven efficacy supports improved disease management and extends established standards of care to younger patients." — Roopal Thakkar, M.D., Chief Scientific Officer, AbbVie, June 26, 2026

"At Week 16 in part 2 of the OptIMMize psoriasis clinical trial program, risankizumab demonstrated clinically meaningful improvements in sPGA and PASI responses², with responses maintained long-term with continued treatment... These clinical responses, combined with weight-based dosing for younger patients, may help physicians better support a broad range of children..." — Amy S. Paller, M.D., Study Investigator and Chair of Dermatology, Northwestern University Feinberg School of Medicine, June 26, 2026