EU approves AbbVie's Skyrizi for children with plaque psoriasis

AbbVie (NYSE: ABBV) announced that the European Commission has approved Skyrizi (risankizumab) for the treatment of children and adolescents six years of age and older 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 less than 40 kg. The decision was supported by data from the Phase 3 OptIMMize-1 pediatric psoriasis program and the Phase 3 OptIMMize-2 open-label extension study. The safety profile observed in 137 pediatric patients treated with Skyrizi was consistent with that seen in adults, with no new safety signals identified.

According to published research cited in the press release, nearly a third of people living with psoriasis develop symptoms before the age of 18, and approximately 70% of pediatric patients rely solely on topical therapies.

Skyrizi is an interleukin-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. The drug is already approved by the European Medicines Agency for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults.

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