SKYRIZI (risankizumab-rzaa)

June 26, 2026: AbbVie (NYSE: ABBV) announced the FDA approved SKYRIZI (risankizumab-rzaa) for pediatric use in psoriatic disease, including (1) children aged 6 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and (2) children aged 6 years and older with active psoriatic arthritis.

The approval also includes a new 55 mg pre-filled syringe to enable weight-based dosing for patients weighing <40 kg; the existing 150 mg pre-filled syringe and pen remain approved for patients weighing ≥40 kg.

AbbVie said the pediatric plaque psoriasis approval is supported by Phase 3 OptIMMize trial program data (NCT04435600; NCT04862286), including pharmacokinetic lead-in cohorts, a randomized assessor-blinded active-controlled cohort (ages 12 to <18), and a single-arm open-label cohort (ages 6 to <12). At Week 16 (part 2), risankizumab showed clinically meaningful improvements in sPGA and PASI responses, with responses maintained long-term with continued treatment. Pediatric safety was reported as consistent with the established adult plaque psoriasis safety profile.

Pediatric psoriatic arthritis approval was supported by the OptIMMize program plus population pharmacokinetic modeling/simulation based on adult psoriatic arthritis studies.