FDA approves risankizumab for pediatric patients with plaque PsO or active PsA

On June 26, 2026, the U.S. Food and Drug Administration (FDA) approved risankizumab for the treatment of pediatric patients aged ≥6 years with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis (PsA).¹ This approval includes a new 55 mg pre-filled syringe to support weight-based dosing for patients weighing <40 kg.¹ 

The approval in pediatric patients with moderate-to-severe plaque PsO was supported by results from the phase III OptIMMize-1 (NCT04435600) and OptIMMize-2 (NCT04862286) trials, including data from two lead-in pharmacokinetic cohorts, a randomized efficacy assessor-blinded active controlled cohort (patients aged 12 to <18 years), and a single-arm open label cohort (patients aged 6 to <12 years).¹ The approval in pediatric patients with active PsA was supported by both the OptIMMize clinical trial program and pharmacokinetic modeling and simulation based on well-controlled adult PsA studies.¹ The safety profile of risankizumab in pediatric patients was consistent with the established safety profile in adult patients with plaque PsO.¹