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European Commission Approves Skyrizi for Pediatric Psoriasis

The European Commission has authorized the use of AbbVie’s Skyrizi for children and adolescents aged six and older suffering from moderate to severe plaque psoriasis. The approval introduces a weight-based dosing regimen with a new 55 mg pre-filled syringe, aiming to address significant clinical gaps for younger patients.

European Commission Approves Skyrizi for Pediatric Psoriasis
Photo: Bio & News

Psoriasis in children frequently manifests on visible areas like the face and scalp, often leading to social stigma, school absenteeism, and an increased risk of long-term comorbidities. Despite this burden, roughly 70 percent of pediatric patients currently rely on topical therapies alone. This new indication provides a systemic treatment option for those who are candidates for such therapy, filling a critical gap in pediatric dermatology.

The regulatory decision follows data from the OptIMMize-1 and OptIMMize-2 trials, which evaluated the safety and efficacy of the IL-23 inhibitor across two age cohorts: six to 12 years and 12 to 18 years. Clinical results showed a safety profile consistent with adult data, with no new signals identified among the 137 pediatric participants. By enabling weight-based dosing, the new 55 mg syringe allows physicians to tailor treatment for patients weighing less than 40 kg, improving the precision of care for a population where early management is vital to preventing disease progression.

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