Regeneron, Sanofi Get EC OK for Dupixent in Adolescents with Atopic Dermatitis

By Colin Kellaher

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi SA (SAN.FR, SNY) on Tuesday said the European Commission extended marketing authorization for Dupixent for moderate-to-severe atopic dermatitis to include adolescents between 12 and 17 years of age.

The companies said Dupixent is the first biologic medicine approved in the EU to treat adolescents with atopic dermatitis, the most common form of eczema.

The approval is based on phase 3 studies that showed Dupixent significantly improved disease extent and severity, skin clearance, and itch intensity, as well as sleep and health-related quality of life.

Regeneron, of Tarrytown, N.Y., created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement. Sanofi markets the product internationally.

Dupixent was previously approved in the EU for adults with moderate-to-severe atopic dermatitis and for adults and adolescents as an add-on maintenance treatment for severe asthma.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

August 06, 2019 09:07 ET (13:07 GMT)

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