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 asthma.

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


(END) Dow Jones Newswires

March 04, 2021 06:11 ET (11:11 GMT)

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