FDA Accepts Priority Review for Sanofi and Regeneron’s Dupixent in Allergic Fungal Rhinosinusitis
Sanofi and Regeneron announced that the FDA has accepted their supplemental biologics license application for Dupixent in treating allergic fungal rhinosinusitis. This application is based on positive Phase 3 study results. The FDA's target action date is February 28, 2026. If approved, Dupixent will be the first medicine specifically indicated for this condition, marking its ninth FDA-approved indication.
Sanofi SA and Regeneron announced that the US Food and Drug Administration (FDA) has accepted for priority review their supplemental biologics license application (sBLA) for Dupixent (dupilumab) in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS). The sBLA is based on positive results from a Phase 3 study showing significant improvements in nasal signs and symptoms compared to placebo. The FDA has set a target action date of February 28, 2026. If approved, Dupixent would become the first and only medicine specifically indicated for AFRS, marking its ninth FDA-approved indication. The application reflects a joint effort between Sanofi and Regeneron. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sanofi SA published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001137611-en) on November 07, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
