EU approves Skyrizi for children with psoriasis

[Fred]

European Commission (EC) approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

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AbbVie today announced that the European Commission (EC) has approved Skrizi (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 (PFS) to support weight-based dosing for patients weighing less than 40 kg.

"Plaque psoriasis in children carries its own clinical complexity and urgency to provide additional efficacious treatment options," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "Today's approval of Skrizi for pediatric psoriasis patients is a meaningful step forward for millions worldwide who are looking for additional treatment options to better manage this chronic disease in their formative years."

Nearly a third of people living with psoriasis develop symptoms before the age of 18, often getting lesions on highly visible areas. Because children often have facial or scalp involvement, the early-onset of psoriasis increases the risk of school absenteeism, potential social stigma, and development of other comorbidities. Despite the significant impact of the disease on children's quality of life, nearly 70% of pediatric patients rely solely on topical therapies.

The EC's approval of Skrizi in pediatric patients is supported by clinical data from the Phase 3 OptIMMize-1 pediatric psoriasis program (NCT04435600), including data from two lead-in pharmacokinetic cohorts: a randomized efficacy assessor-blinded, active-controlled cohort (12 to <18 years), and a single-arm, open-label cohort (6 to <12 years), in addition to the Phase 3 OptIMMize-2 open-label extension study (NCT04862286). The safety profile in pediatric patients (n=137) treated with Skyrizi was consistent with that observed in adults with moderate to severe plaque psoriasis, with no new safety signals observed.

"Particularly for pediatric psoriasis patients, early diagnosis and management can prevent symptoms from worsening and improve quality of life in the long-term," said Nina Magnolo, M.D., Department of Dermatology, University Hospital of Münster, and lead investigator of the OptIMMize-1 study. "The EC's approval of risankizumab provides younger patients with more options including weight-based dosing and allows physicians to address unmet clinical needs of children living with moderate to severe psoriasis with confidence."

Source: abbvie.com

Skyrizi (risankizumab)