AbbVie Announces European Commission Approval of SKYRIZI® (risankizumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis

The European Commission has approved SKYRIZI (risankizumab) for the treatment of children and adolescents aged six and older with moderate to severe plaque psoriasis. This regulatory decision, announced by AbbVie on June 23, 2026, expands the use of the IL-23 inhibitor to include younger patients who are candidates for systemic therapy and introduces a 55 mg pre-filled syringe designed to facilitate weight-based dosing for those weighing less than 40 kg.

Did You Know? Nearly 70% of pediatric patients with plaque psoriasis currently rely solely on topical therapies, despite the condition’s significant impact on quality of life and the frequent appearance of lesions on highly visible areas like the face and scalp.

Clinical Evidence for Pediatric Use

The approval is based on findings from the Phase 3 OptIMMize-1 pediatric psoriasis program. According to AbbVie, the clinical data included results from two lead-in pharmacokinetic cohorts and a randomized, efficacy assessor-blinded, active-controlled cohort. In the study, 137 pediatric patients received the treatment, and researchers reported that the safety profile remained consistent with observations in adult populations, with no new safety signals identified during the trial.

Why Early Intervention Matters

Early diagnosis and management are essential to prevent the progression of symptoms and mitigate long-term impacts on a child’s quality of life. Dr. Nina Magnolo of the University Hospital of Münster, the lead investigator of the OptIMMize-1 study, noted that the approval allows physicians to address the unmet clinical needs of younger patients with greater confidence. The condition is associated with risks beyond physical lesions, including school absenteeism, potential social stigma, and the development of various comorbidities.

Expert Insight: The introduction of a 55 mg pre-filled syringe represents a practical shift in pediatric care, moving away from “one-size-fits-all” dosing toward precision medicine. By tailoring the delivery method to weight, clinicians may reduce the barriers that have historically kept 70% of the pediatric population on limited topical treatments, potentially allowing them to transition to systemic options earlier in their formative years.

What May Happen Next

Following this European Commission approval, healthcare providers in the region may begin incorporating the weight-based dosing regimen into their standard treatment protocols for pediatric plaque psoriasis. As the therapy becomes more widely available, clinical outcomes for younger patients could be monitored to see if the availability of systemic treatment leads to a reduction in reported school absenteeism and social stigma. Future clinical observations may further validate the long-term efficacy of this IL-23 inhibitor in this specific demographic.

Frequently Asked Questions

Who is eligible for this treatment?
The approval covers children and adolescents six years of age and older who have moderate to severe plaque psoriasis and are candidates for systemic therapy.

How is the dosage managed for younger patients?
The treatment now includes a new 55 mg pre-filled syringe specifically designed to support weight-based dosing for patients weighing less than 40 kg.

What are the primary safety considerations?
Risankizumab is contraindicated in patients with hypersensitivity to the active substance or its excipients, and those with clinically important active infections, such as active tuberculosis. Common adverse reactions include upper respiratory infections.

How might the availability of weight-based systemic therapies change the daily lives of children currently managing moderate to severe plaque psoriasis?