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: 04 Mar 2026

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At a glance

24 Feb 2026 According to a Sanofi media release, the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery. The FDA evaluated Dupixent under priority review for the treatment of AFRS. The FDA approval is supported by the LIBERTY-AFRS-AIMS, Additional submissions are planned to other regulatory authorities around the world.
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.

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