Regeneron, Sanofi Get EC OK for Dupixent in Adolescents with Atopic Dermatitis
August 06 2019 - 9:22AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 06, 2019 09:07 ET (13:07 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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