EU Approves Dupixent for Adolescent Eczema

By Reuters Staff

August 07, 2019

PARIS (Reuters) - Dupixent (dupilumab) has won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents, Sanofi and Regeneron said.

The European Commission has extended the marketing authorization for Dupixent in the European Union to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy, Sanofi and Regeneron said in a joint statement on Tuesday.

Sanofi also announced on Tuesday that a phase 3 trial of Dupixent for severe atopic dermatitis in children aged 6 to 11 years met its primary and secondary endpoints.

Dupixent is an important driver of growth for both Sanofi and Regeneron, given the competition on Regeneron's flagship eye drug Eylea and pressures on Sanofi's diabetes business.

"Adolescents with moderate-to-severe atopic dermatitis in the EU now have an approved biologic medicine that can significantly control persistent, debilitating symptoms such as itch and skin lesions, as well as improve sleep, which is particularly critical during these formative years," said George Yancopoulos, chief scientific officer, Regeneron.

The EU's latest approval for Dupixent also comes after the U.S. Food & Drug Administration (FDA) in June approved Dupixent to treat nasal polyps.

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