FDA Approves Skyrizi for Pediatric Psoriatic Disease

Skyrizi (risankizumab) Approved for Pediatric Psoriatic Diseases

The FDA approved risankizumab-rzaa (Skyrizi, AbbVie) for pediatric use in psoriatic disease, according to a June 26 press release from AbbVie. The approval covers children 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as children in the same age group with active psoriatic arthritis.

The approval includes a new 55mg prefilled syringe to support weight-based dosing in patients weighing less than 40kg. The existing 150mg syringe and pen are approved for patients weighing 40kg or more. AbbVie said Skyrizi is the first and only interleukin-23 (IL-23) inhibitor approved in the United States for pediatric patients aged 6 years or older and weighing less than 40kg with plaque psoriasis or psoriatic arthritis.

The pediatric plaque psoriasis indication was supported by data from the phase 3 OptIMMize psoriasis clinical trial program (NCT04435600; NCT04862286). The program included two lead-in pharmacokinetic cohorts, a randomized, efficacy assessor-blinded, active-controlled cohort involving adolescents aged 12 to younger than 18 years, and a single-arm, open-label cohort involving children aged 6 to younger than 12 years. AbbVie reported that risankizumab produced clinically meaningful improvements in sPGA and PASI responses at week 16, with responses maintained during continued treatment.

Support for the pediatric psoriatic arthritis indication came from the OptIMMize psoriasis program and population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies. According to AbbVie, the safety profile observed among pediatric patients with plaque psoriasis was consistent with the established safety profile in adults with plaque psoriasis.

AbbVie reported that approximately 30% of people who develop psoriasis experience symptoms before age 18 years. The company also cited estimates that approximately 20,000 US children younger than 10 years are diagnosed with psoriasis annually and that about 14,000 children are affected by psoriatic arthritis.

Source: AbbVie. SKYRIZI® (risankizumab-rzaa) now FDA approved for pediatric use in psoriatic disease. Press release. AbbVie; June 26, 2026. Accessed June 29, 2026.