The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion recommending an expansion of the marketing authorization for Skyrizi (risankizumab, AbbVie) to include children and adolescents aged 6 years or older with moderate-to-severe plaque psoriasis who require systemic therapy. 

Skyrizi, an interleukin-23 (IL-23) inhibitor, was first granted EU-wide marketing authorization for plaque psoriasis in adults on April 26, 2019. The new recommendation would extend that plaque psoriasis indication to a pediatric population.

Beyond plaque psoriasis, Skyrizi remains authorized for adults with active psoriatic arthritis — either alone or in combination with methotrexate — and for adults with moderately to severely active Crohn’s disease or ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional or biologic therapy.

Targeting IL-23 Pathway 

Skyrizi contains risankizumab, humanized monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 contributes to inflammation associated with arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. By blocking IL-23 action, risankizumab reduces inflammation and related symptoms in these conditions.

Administration and Dosing 

For plaque psoriasis and psoriatic arthritis, Skyrizi is available as prefilled syringes and prefilled pens for subcutaneous injection into areas not affected by psoriasis, such as the thigh or abdomen. The initial two doses are administered 4 weeks apart, followed by subsequent doses every 12 weeks. Healthcare providers may discontinue treatment if the condition fails to improve after 16 weeks. After appropriate training, patients or caregivers may administer injections when deemed suitable by their physician.

Pediatric Efficacy and Safety 

The pediatric authorization builds evidence from the phase 3 OptIMMize-1 study, which demonstrated that risankizumab treatment maintained or improved clinical responses through 52 weeks in children and adolescents with psoriasis.

Among 30 children aged 6 to < 12 years who received open label risankizumab for 52 weeks, 86.7% achieved a 75% reduction in Psoriasis Area and Severity Index (PASI 75) score, 80.0% reached PASI 90, and 63.3% attained PASI 100. Clear or almost clear skin was observed in 83.3% of these younger patients.

The safety profile in pediatric populations remained consistent with that observed in adult psoriasis studies, with no new safety concerns identified. 

Detailed recommendations for Skyrizi use will be outlined in the updated Summary of Product Characteristics, which will be published on the EMA website in all official European Union languages following European Commission approval of this marketing authorization change.