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

The drug is now approved to treat nine distinct diseases driven in part by type 2 inflammation.

Published on Feb. 24, 2026

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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 (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.

Why it matters

This approval makes Dupixent the first drug approved in the U.S. for AFRS, expanding the drug's reach to treat a wider range of type 2 inflammatory diseases. Dupixent is a key revenue driver for Regeneron and Sanofi, with global net sales reaching roughly $18.5 billion last year.

The details

Regeneron and Sanofi said the approval covers Dupixent in people ages six and older with AFRS who have a history of sino-nasal surgery. Dupixent is now approved in the U.S. to treat nine distinct diseases driven in part by type 2 inflammation.

  • Regeneron and Sanofi announced the FDA approval on February 24, 2026.

The players

Regeneron Pharmaceuticals

A biotechnology company based in Tarrytown, New York that created Dupixent and markets it jointly in the U.S. with Sanofi.

Sanofi

A French pharmaceutical company that markets Dupixent internationally and collaborates with Regeneron on the drug.

U.S. Food and Drug Administration (FDA)

The federal agency that granted expanded approval for Dupixent to treat allergic fungal rhinosinusitis.

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The takeaway

This approval expands the reach of Dupixent, a key revenue driver for Regeneron and Sanofi, to treat a wider range of type 2 inflammatory diseases including the chronic condition of allergic fungal rhinosinusitis.