Regeneron, Sanofi Get FDA Priority Review of Dupixent in Children With Atopic Dermatitis
January 28 2020 - 6:30AM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. (REGN) and Sanofi S.A. (SAN.FR)
on Tuesday said the U.S. Food and Drug Administration accepted for
priority review their supplemental biologics license application
for Dupixent for children with moderate-to-severe atopic
dermatitis.
The companies said the application covers Dupixent as an add-on
maintenance treatment for children ages 6 to 11 years with the skin
condition whose disease isn't adequately controlled with topical
prescription therapies or when those therapies aren't
advisable.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period to
six months from the standard 10 months. The agency set a target
action date of May 26 for the Dupixent sBLA.
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.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 28, 2020 06:15 ET (11:15 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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