European Commission has extended marketing authorisation for Dupixent European Union to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis
The Dupixent product developed by French healthcare company Sanofi and its US partner Regeneron has won regulatory approval in Europe for moderate-to-severe cases of eczema in adolescents, the companies said.
The European Commission has extended the marketing authorisation 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.
Atopic dermatitis, more commonly known as eczema, often leads to skin irritations.
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.
Last month, Sanofi reported a surge in Dupixent’s sales as the company posted strong second-quarter results.
The EU’s latest approval for Dupixent also comes after the US Food and Drug Administration (FDA) regulator in June approved Dupixent to treat nasal polyps.