As reported on Becker’s Hospital Review, the FDA has approved risankizumab (Skyrizi) for use in children and adolescents aged 6 years and older with moderate-to-severe plaque psoriasis who are appropriate candidates for systemic treatment or phototherapy. The expanded indication also covers pediatric patients with active psoriatic arthritis.
With this authorization, risankizumab becomes the first IL-23 inhibitor approved in the United States for these pediatric indications. The approval is accompanied by the availability of a new 55-mg prefilled syringe, developed to enable weight-based dosing for patients weighing less than 40 kg.
The FDA’s decision was based on findings from the Phase 3 OptIMMize clinical trial program in pediatric plaque psoriasis. At Week 16, patients receiving risankizumab experienced significant improvements in disease severity, as measured by static Physician’s Global Assessment (sPGA) and Psoriasis Area and Severity Index (PASI) response rates. Investigators reported that these treatment benefits were sustained with ongoing therapy.
Safety data from the pediatric study population aligned with the established safety profile previously observed in adults treated with risankizumab, with no unexpected safety signals identified.
Plaque psoriasis is a chronic immune-mediated condition that can cause considerable physical and emotional burden in children and adolescents. The expanded approval provides healthcare professionals with an additional biologic treatment option that targets the IL-23 pathway, a key contributor to the inflammatory processes involved in both plaque psoriasis and psoriatic arthritis.
The approval represents an important step in broadening treatment options for pediatric patients who require advanced therapies to manage moderate-to-severe disease and improve long-term outcomes.
