Sanofi’s Dupixent extended in Europe to cover adolescents in atopic dermatitis
Sanofi has announced that European Commission (EC) has chosen to extend the marketing approval of its interleukin-4 (IL-4) and interleukin-13 (IL-13) inhibitor Dupixent (dupilumab) to cover the treatment of adolescent patients aged between 12 and 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
The ruling makes Dupixent the first biologic medicine approved in the EU. The Phase 3 data unveiled by Sanofi included a series of strong showings for the drug after 16 weeks of treatment: firstly, 42% of Dupixent patients saw a skin improvement of 75% or greater, according to the Eczema Area and Severity Index (EASI-75), compared to just 8% of placebo patients, meeting the trial’s co-primary endpoint. As far the other co-endpoint, 24% of Dupixent patients achieved clear or almost clear skin, represented by a score of 0 or 1 on an Investigator’s Global Assessment (IGA), compared to 2% with placebo.
Additionally, 66% of Dupixent patients saw a 66% improvement on average in the EASI score of inflammation from baseline compared to 24% with placebo, 61% saw a clinically meaningful improvement in quality of life of at least six points on the Children’s Dermatology Life Quality Index (CDLQI) compared to 20% with placebo, and 63% saw an improvement in disease severity, as shown by an improvement of at least six points on the Patient Oriented Eczema Measure scale compared to 10% with placebo.
“Adolescents with moderate-to-severe atopic dermatitis in the EU now have an approved biologic medicine that can significantly control persistent, debilitating symptoms like itch and skin lesions, as well as improve sleep, which is particularly critical during these formative years,” said Dr George D Yancopoulos, President and Chief Scientific Officer at Regeneron. “Today’s approval also provides these young patients with a treatment option that addresses the type 2 inflammation that underlies atopic dermatitis. In addition to its approved uses in atopic dermatitis and asthma in the EU, we continue to investigate Dupixent in a broad range of patients with other type 2 inflammatory diseases.”
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