By Colin Kellaher

Regeneron Pharmaceuticals and Sanofi have won Food and Drug Administration priority review of their application seeking expanded approval of their blockbuster anti-inflammatory drug Dupixent for adolescents with a sinus condition that can lead to a loss of the sense of smell.

Regeneron and Sanofi on Monday said the application covers Dupixent as an add-on maintenance treatment for patients ages 12 to 17 with inadequately controlled chronic rhinosinusitis with nasal polyposis, or CRSwNP.

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. The agency has set a target action date of Sept. 15 for the application.

Regeneron and Sanofi said an FDA green light would make Dupixent the first treatment in the U.S. for those ages 12 to 17 with inadequately controlled CRSwNP, which is driven in part by an underlying type 2 inflammation that obstructs the sinuses and nasal passages. Dupixent is currently approved as an add-on maintenance treatment for adults with CRSwNP whose disease isn't adequately controlled.

Tarrytown, N.Y., biotechnology company Regeneron created Dupixent and markets it jointly in the U.S. with France's Sanofi under a 2007 collaboration agreement, while Sanofi markets the product internationally. The drug generated roughly $11.6 billion in sales last year.

Write to Colin Kellaher at

(END) Dow Jones Newswires

05-13-24 0624ET