NORTH CHICAGO, Ill., June 26, 2026
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved 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, as well as active psoriatic arthritis. The approval also includes a new 55 mg pre-filled syringe designed for weight-based dosing in patients weighing less than 40 kilograms, while the existing 150 mg pre-filled syringe and pen remain available for patients weighing 40 kilograms or more. With this decision, SKYRIZI becomes the first and only IL-23 inhibitor approved in the United States for pediatric patients aged six years and older weighing less than 40 kg with plaque psoriasis or psoriatic arthritis, expanding treatment options for children living with chronic immune-mediated diseases.
Phase 3 OptIMMize Trial Demonstrated Durable Clinical Benefits
The FDA approval is supported by results from the Phase 3 OptIMMize clinical trial program, which evaluated SKYRIZI in pediatric patients with plaque psoriasis through pharmacokinetic studies, a randomized active-controlled cohort involving adolescents aged 12 to under 18 years, and an open-label cohort for children aged 6 to under 12 years. The approval for pediatric psoriatic arthritis was further supported by population pharmacokinetic modeling using data from well-controlled adult studies. Clinical findings demonstrated meaningful improvements in Static Physician’s Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI) responses by Week 16, with benefits maintained during long-term treatment. The safety profile observed in pediatric patients remained consistent with the established safety profile in adults, reinforcing confidence in the therapy across multiple age groups.
New Pediatric Dosing Expands Access to Advanced IL-23 Therapy
Approximately 30% of individuals with psoriasis develop symptoms before the age of 18, with an estimated 20,000 children under ten years old diagnosed annually in the United States and roughly 14,000 children living with psoriatic arthritis. These chronic inflammatory conditions can significantly affect physical activity, emotional well-being, school participation, and overall quality of life. The approval of the 55 mg pre-filled syringe enables precise weight-based dosing for younger and lighter patients, allowing physicians to deliver SKYRIZI across a broader pediatric population. The therapy selectively targets the IL-23 p19 subunit, a cytokine involved in chronic inflammatory diseases, providing a targeted treatment approach designed to improve long-term disease control while reducing symptoms affecting both the skin and joints.
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AbbVie Strengthens Pediatric Immunology Leadership with SKYRIZI Expansion
The latest FDA approval further expands AbbVie’s immunology portfolio, extending SKYRIZI’s approved indications beyond adults to include children with plaque psoriasis and psoriatic arthritis. The medicine is already approved in the United States and Europe for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, making it one of the company’s leading immunology therapies. To support patient access, AbbVie continues to offer financial assistance programs, including commercial co-pay support and myAbbVie Assist for eligible uninsured or underinsured patients. The pediatric approval represents another milestone in expanding access to advanced biologic therapies, providing physicians and families with a new treatment option backed by Phase 3 clinical evidence, established safety data, and targeted IL-23 inhibition for managing chronic immune-mediated diseases in younger patients.
Source: AbbVie press release
