Trial Profile

A Randomized Double-blind Placebo-controlled Parallel Group Study Assessing the Efficacy and Safety of Dupilumab in Patients With Allergic Fungal Rhinosinusitis (AFRS)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 24 Dec 2025

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At a glance

07 Nov 2025 According to a Sanofi media release, Dupixent sBLA accepted for priority review by the U.S. FDA with a target action date of February 28, 2026.
07 Nov 2025 Results presented in a Regeneron Pharmaceuticals media release.
07 Nov 2025 According to Regeneron Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent in adults and children aged 6 years and older with AFRS. Priority Review is granted by the FDA to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

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