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On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application ("sBLA") for Dupixent (dupilumab) in the treatment of adults and children aged 6 years and older with allergic fungal rhinosinusitis ("AFRS"), with a target action date of February 28, 2026. The FDA awards priority review status to applications for therapies that may offer substantial therapeutic advances for serious medical conditions.
AFRS is a chronic type 2 inflammatory disease of the sinuses caused by an intense allergic hypersensitivity to fungi. If approved, AFRS would be the ninth FDA-approved indication for Dupixent and would make it the first and only medicine indicated specifically for AFRS. Sanofi and Regeneron's sBLA is supported by positive results from the LIBERTY-AFRS-AIMS phase 3 study, which met all primary and secondary endpoints, demonstrating significant reductions in key disease signs and symptoms including sinus opacification, nasal congestion, and nasal polyps compared to placebo.
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