Risankizumab approved by the EC for moderate-to-severe pediatric plaque psoriasis

On June 23, 2026, the European Commission (EC) approved risankizumab for the treatment of children and adolescents aged ≥6 years with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The approval includes a new 55 mg pre-filled syringe to support weight-based dosing for patients weighing <40 kg. 

The EC approval was supported by clinical data from the phase III OptIMMize-1 pediatric psoriasis program (NCT04435600), including two lead-in pharmacokinetic cohorts: a randomized, efficacy assessor-blinded, active-controlled cohort in patients aged 12 to <18 years, and a single-arm, open-label cohort in patients aged 6 to <12 years. The approval was also supported by findings from the phase III OptIMMize-2 open-label extension study (NCT04862286). The safety profile of risankizumab in pediatric patients (n = 137) was consistent with that observed in adults with moderate-to-severe plaque psoriasis, with no new safety signals reported.