Clinical Report: FDA Approves Pediatric Risankizumab

Overview

The FDA has approved risankizumab for pediatric patients aged 6 years and older with moderate to severe plaque psoriasis and active psoriatic arthritis. This approval includes a new 55-mg prefilled syringe for patients weighing less than 40 kg.

Background

Psoriasis and psoriatic arthritis can significantly impact the quality of life in pediatric patients, with approximately 30% of psoriasis cases beginning before age 18.

Data Highlights

The pediatric plaque psoriasis indication is supported by the phase 3 OptIMMize clinical trial program, which included various cohorts of patients aged 6 to 18 years.

Key Findings

• Risankizumab is the first IL-23 inhibitor approved for pediatric patients aged 6 years and older in the US.
• The approval includes a 55-mg prefilled syringe for patients weighing less than 40 kg.
• Approximately 20,000 children under 10 years are diagnosed with psoriasis annually in the US.
• The safety profile in pediatric patients is consistent with that observed in adults.
• At Week 16, risankizumab demonstrated clinically meaningful improvements in psoriasis severity measures.

Clinical Implications

Healthcare providers should monitor patients for infections and tuberculosis prior to initiating treatment.

Conclusion

The FDA has approved risankizumab for pediatric use.

Related Resources & Content

1. AbbVie, PR Newswire, 2026 -- SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease
2. American Academy of Dermatology, Pediatric psoriasis guideline
3. ScienceDirect, 2026 -- Efficacy and Safety of Risankizumab in Pediatric Patients With Psoriasis: Results From the OptIMMize-1 Phase 3 Study
4. The New Gastroenterologist — FDA Grants Approval for Simponi in Treating Pediatric Ulcerative Colitis
5. conexiant — FDA Expands ASCENIV Pediatric Use
6. The New Gastroenterologist — Mirikizumab demonstrates potential benefits for children suffering from ulcerative colitis
7. conexiant — Tzield Approval Expands to Younger Patients
8. Pediatric psoriasis guideline
9. Efficacy and Safety of Risankizumab in Pediatric Patients With Psoriasis: Results From the OptIMMize-1 Phase 3 Study - ScienceDirect
10. SKYRIZI® (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease
11. Skyrizi (AbbVie Inc.): FDA Package Insert