Sanofi and Regeneron's Dupixent gets FDA priority review for allergic fungal rhinosinusitis

Sanofi and Regeneron announced on November 7, 2025, that the U.S. Food and Drug Administration (FDA) has accepted their supplemental biologics license application (sBLA) for Dupixent (dupilumab) for priority review in treating allergic fungal rhinosinusitis (AFRS).

Phase 3 study results, presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, showed that Dupixent significantly reduced key signs and symptoms of AFRS, including sinus opacification and nasal congestion, compared to placebo. These are the first positive Phase 3 results specifically for AFRS.

AFRS is a chronic type 2 inflammatory disease of the sinuses caused by hypersensitivity to fungi. It is often difficult to treat and can lead to nasal polyps, loss of smell, and may require surgery. If approved, Dupixent would become the first and only medicine specifically indicated for AFRS.

The FDA has assigned a target action date of February 28, 2026. This potential approval would mark the ninth FDA-approved indication for Dupixent.