Regeneron, Sanofi Get Speedy FDA Review of Dupixent in COPD

By Colin Kellaher

Regeneron Pharmaceuticals and Sanofi have won U.S. Food and Drug Administration priority review for their application seeking expanded approval of Dupixent in chronic obstructive pulmonary disease, potentially adding a sixth U.S. indication for their blockbuster anti-inflammatory drug.

Regeneron and Sanofi on Friday said the application covers Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease, or COPD.

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 June 27 for the application.

Regeneron and Sanofi said an FDA green light would make Dupixent the only biologic therapy for COPD and the first new treatment approach for the disease in more than a decade.

Regulatory submissions also are under review in China and Europe, the companies said.

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 colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 23, 2024 06:15 ET (11:15 GMT)

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