Biopharmaceutical leader AbbVie has announced that the European Commission (EC) has formally granted marketing authorization expanding the indication for its biologic therapy Skyrizi (risankizumab). Executed on June 23, 2026, the regulatory greenlight clears Skyrizi for the treatment of children and adolescents aged six years and older presenting with moderate to severe plaque psoriasis who are eligible candidates for systemic therapy.
The regulatory mandate integrating a novel 55 mg pre-filled syringe configuration to support weight-based pediatric dosing alongside core clinical data from the OptIMMize trial registry features:
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Pediatric Disease Burden and the Weight-Based Dosing Architecture:
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Clinical Vulnerabilities: Epidemiological data indicates that nearly one-third of individuals living with psoriasis manifest clinical symptoms before the age of 18. Because pediatric lesions frequently involve highly visible regions like the face or scalp, early-onset disease accelerates the risk of school absenteeism, social stigma, and the development of secondary comorbidities. Despite this severe impact on quality of life, approximately 70% of pediatric patients currently rely exclusively on suboptimal topical regimens.
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55 mg Formulations: To systematically resolve pediatric treatment barriers, the EC approval incorporates a novel 55 mg pre-filled syringe (PFS) presentation. The low-dose hardware enables clinicians to execute precise, weight-based dosing schedules tailored specifically for younger patients weighing less than 40 kg.
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Clinical Foundations Anchored by the OptIMMize-1 and OptIMMize-2 Trials:
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Trial Demographics: The EC’s expanded pediatric approval is structurally validated by clinical readouts derived from the Phase III OptIMMize-1 pediatric psoriasis program. The testing framework evaluated two lead-in pharmacokinetic cohorts: a randomized, efficacy assessor-blinded, active-controlled cohort (ages 12 to <18) and a single-arm, open-label cohort (ages 6 to <12), supplemented by long-term data from the Phase III OptIMMize-2 open-label extension study.
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Safety Profiles: Clinical tracking across the pediatric safety cohort (n=137) confirmed that the tolerability profile of Skyrizi in children remained entirely consistent with historical baselines observed in adult populations managing moderate to severe plaque psoriasis, revealing zero novel safety signals or toxicities.
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Molecular Kinetic Subunits and Mandatory Biological Safety Provisos:
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Mechanism of Action: Skyrizi functions as a highly targeted interleukin-23 (IL-23) inhibitor, selectively binding to the p19 subunit of the pro-inflammatory cytokine to halt downstream immune-mediated chronic cascades. Beyond the updated pediatric label, the biologic holds global regulatory approvals across adult indications for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
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Strict Contraindications: According to the EMA-validated prescribing information, risankizumab is strictly contraindicated in patients exhibiting hypersensitivity to the molecule and individuals presenting with clinically important active infections, such as active tuberculosis (TB). Patients must undergo rigorous TB screenings and update routine immunizations before starting therapy. Crucially, live viral or bacterial vaccines are prohibited during treatment and must be withheld for at least 21 weeks following the final dose of Skyrizi. Upper respiratory tract infections represented the most frequently reported adverse event, tracking at 13% within the psoriasis clinical trials.
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