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

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

Published on Feb. 24, 2026

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Regeneron Pharmaceuticals and Sanofi have received U.S. Food and Drug Administration expanded approval for their blockbuster anti-inflammatory drug Dupixent to treat certain patients with allergic fungal rhinosinusitis (AFRS), a chronic inflammatory disease of the sinuses. Dupixent is now approved in the U.S. to treat nine distinct diseases driven in part by type 2 inflammation.

Why it matters

This approval marks the first drug approved in the U.S. for AFRS, a condition characterized by an allergic hypersensitivity to fungi that can cause severe nasal congestion and other debilitating symptoms. The expanded approval for Dupixent provides a new treatment option for patients suffering from this chronic condition.

The details

Regeneron and Sanofi said the FDA approval covers Dupixent for people ages six and older with AFRS who have a history of sino-nasal surgery. Dupixent is a monoclonal antibody that works by inhibiting the inflammatory pathway underlying AFRS and other type 2 inflammatory diseases.

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

The players

Regeneron Pharmaceuticals

A biotechnology company that created and co-markets Dupixent with Sanofi under a 2007 collaboration agreement.

Sanofi

A French pharmaceutical company that co-markets Dupixent with Regeneron in the U.S. and markets the drug internationally.

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 treatment options for patients suffering from the chronic and debilitating condition of allergic fungal rhinosinusitis, providing a new FDA-approved therapy to help manage their symptoms and improve their quality of life.