Regeneron, Sanofi Get FDA Approval For Dupixent in Allergic Fungal Rhinosinusitis

By Colin Kellaher

Regeneron Pharmaceuticals and Sanofi have won U.S. Food and Drug Administration expanded approval of their blockbuster anti-inflammatory drug Dupixent for certain patients with allergic fungal rhinosinusitis, or AFRS.

Regeneron and Sanofi on Tuesday said the approval covers Dupixent in people ages six and older with AFRS who have a history of sino-nasal surgery.

The companies said the green light makes Dupixent the first drug approved in the U.S. for AFRS, a chronic inflammatory disease of the sinuses characterized by an allergic hypersensitivity to fungi that can leave patients with inflamed nasal passages, nasal polyps and thick mucus causing constant nasal congestion.

Dupixent is now approved in the U.S. to treat nine distinct diseases driven in part by type 2 inflammation.

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 drug internationally.

Dupixent global net sales reached roughly $18.5 billion last year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 24, 2026 10:04 ET (15:04 GMT)