Dupixent becomes first systemic medicine approved in Europe for children with severe atopic dermatitis
The European Commission has moved to expand the existing authorisation of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union to include the treatment of severe atopic dermatitis in paediatric patients between the age of six and 11 and are eligible to receive systemic therapy.
Phase 3 data supporting the decision compared a weight-based dosage of Dupixent administered every four and two weeks in combination with topical corticosteroids administered to topical corticosteroids and placebo in this patient population.
After 16 weeks, patients receiving the Dupixent combo saw an average improvement of 82% and 80% every four and two weeks in disease extent and severity, compared to an improvement of 49% and 48% in the placebo group. Over the same time period, 70% and 75% of Dupixent patients experienced an improvement of at least 75% from baseline, while just 17% and 26% of patients in the placebo group experienced the same.
In addition, 33% and 39% of Dupixent patients reported total or almost total skin clearance every four or two weeks, compared to 11% and 10% with placebo, while 51% and 61% receiving Dupixent saw a “clinically significant” reduction in itching over the same period compared to 12% and 13% with placebo.
“As the parent of a child with atopic dermatitis, and someone who works with families impacted by this condition daily, I’ve seen first-hand the enormous physical and mental health burden of this disease, and the toll it can take on the entire family,” remarked Korey Capozza, Founder and Executive Director of Global Parents for Eczema Research (GPER). “Young children with severe atopic dermatitis currently have few treatment choices and significant unmet needs. We welcome the addition of new medicines for these underserved patients.”
The Commission’s decision marks the first approval of a systemic medicine in the EU to treat this patient population.
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