Regeneron, Sanofi Get FDA Priority Review for Dupixent
March 08 2019 - 6:40AM
Dow Jones News
By Colin Kellaher
Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SAN.FR, SNY)
on Friday said the U.S. Food and Drug Administration accepted and
granted priority review to their supplemental biologics-license
application for Dupixent in a chronic upper-airway disease.
The companies said the sBLA covers Dupixent as an add-on
maintenance treatment for adults with inadequately controlled
severe chronic rhinosinusitis with nasal polyps, who often
experience recurrence despite previous treatment with surgery or
corticosteroids.
Regeneron and Sanofi said there are currently no FDA-approved
biologic medicines to treat the disease, which is characterized by
polyps that obstruct the sinuses and nasal passages.
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 June 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
March 08, 2019 06:25 ET (11:25 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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