FDA approves AbbVie’s SKYRIZI (risankizumab‑rzaa) for children aged six and older with moderate‑to‑severe plaque psoriasis and active psoriatic arthritis, introducing a new 55 mg pre‑filled syringe for weight‑based dosing under 40 kg.
Written By: Kalyani Boharapi, PharmD
Reviewed By: Pharmacally Editorial Team
The U.S. Food and Drug Administration (FDA) has approved SKYRIZI (risankizumab-rzaa) for children aged 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis (PsA). The approval expands AbbVie’s immunology portfolio into pediatric inflammatory diseases and includes a new 55 mg pre-filled syringe (PFS) for weight-based dosing in patients weighing less than 40 kg. Children weighing 40 kg or more will continue to receive the approved 150 mg PFS or pen.
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 IL-23 Inhibition to Pediatric Immune-Mediated Disease
Risankizumab is a selective interleukin-23 (IL-23) inhibitor that targets the p19 subunit of IL-23, a cytokine that drives chronic inflammation in psoriasis and psoriatic arthritis. By blocking IL-23 signaling, the therapy reduces skin and joint inflammation associated with these immune-mediated diseases.
Nearly one-third of people with psoriasis develop symptoms before 18 years of age. In the United States, about 20,000 children younger than 10 years are diagnosed with psoriasis each year, while an estimated 14,000 children are affected by psoriatic arthritis. Both conditions can impair mobility, daily activities, and quality of life while increasing the burden on caregivers.
Phase 3 OptIMMize Program Supported the Approval
The pediatric plaque psoriasis indication is supported by the Phase 3 OptIMMize clinical trial program (NCT04435600; NCT04862286), which included two pharmacokinetic lead-in cohorts, a randomized efficacy assessor-blinded active-controlled cohort in adolescents aged 12 to younger than 18 years, and a single-arm open-label cohort in children aged 6 to younger than 12 years.
At Week 16 of Part 2, risankizumab demonstrated clinically meaningful improvements in Static Physician’s Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI) responses, with benefits maintained during long-term treatment.
The pediatric psoriatic arthritis approval was supported by the OptIMMize psoriasis program together with population pharmacokinetic modeling and simulation using data from well-controlled adult psoriatic arthritis studies.
The safety profile in pediatric patients was consistent with the established adult experience, with no new safety concerns identified. The newly approved 55 mg pre-filled syringe also enables weight-based dosing for children weighing less than 40 kg.
Expanding Treatment Options for Children
AbbVie Chief Scientific Officer Roopal Thakkar, MD, said the approval extends established standards of care to younger patients living with chronic inflammatory diseases affecting both the skin and joints. He noted that broader access to an IL-23 inhibitor may improve long-term disease management for affected families.
Amy S. Paller, MD, Chair of Dermatology and Professor of Pediatrics at Northwestern University Feinberg School of Medicine and an OptIMMize investigator, said the sustained Week 16 responses and weight-based dosing provide physicians with greater flexibility when treating pediatric plaque psoriasis and psoriatic arthritis.
Broadening SKYRIZI’s Commercial Footprint
The expanded indication extends SKYRIZI’s reach beyond adult inflammatory diseases, strengthening its position across dermatology, rheumatology, and gastroenterology. The therapy is already approved in the United States for adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. AbbVie will continue supporting patient access through its co-pay assistance and myAbbVie Assist programs. With this pediatric expansion, SKYRIZI now spans dermatology, rheumatology, and gastroenterology across both adult and pediatric populations, reinforcing AbbVie’s leadership in IL-23 inhibition.
What This Means for Patients
This approval gives children aged 6 years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis access to an additional treatment option that was previously approved only for adults. The newly approved 55 mg pre-filled syringe also allows doctors to adjust the dose based on a child’s body weight, making treatment suitable for younger children weighing less than 40 kg.
For children and their families, the expanded approval offers another proven treatment to help control skin and joint symptoms. Better disease management may reduce pain, itching, and swelling, improve movement and daily activities, and help children participate more comfortably in school, sports, and other aspects of everyday life. Earlier access to effective treatment may also help reduce the long-term impact of these chronic inflammatory conditions.
Reference
SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease – Jun 26, 2026
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.