Regeneron, Sanofi: FDA to Review Dupixent for Asthma Attacks in Children
By Colin Kellaher
Regeneron Pharmaceuticals Inc. and Sanofi SA on Thursday said
the U.S. Food and Drug Administration accepted their application
for expanded approval of Dupixent as an add-on treatment for
children ages six to 11 with uncontrolled moderate-to-severe
The companies said the agency set a target action of Oct. 21 for
a decision, adding that they plan to file for European Union
approval in the same age group by the end of the month.
The blockbuster eczema drug is already approved as an add-on
treatment for patients ages 12 and older with uncontrolled
moderate-to-severe asthma with elevated eosinophils or oral
corticosteroid dependent asthma.
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 firstname.lastname@example.org
(END) Dow Jones Newswires
March 04, 2021 06:11 ET (11:11 GMT)
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