French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) on Friday announced positive results from the phase 3 LIBERTY-AFRS-AIMS study evaluating Dupixent (dupilumab) in patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS).

The trial met all primary and secondary endpoints, significantly reducing sinus opacification, nasal congestion, and nasal polyps compared with placebo.

The US FDA has accepted the supplemental biologics license application (sBLA) for Dupixent in AFRS for priority review, with a target action date of 28 February 2026. If approved, AFRS would become the ninth FDA-approved indication for Dupixent.

AFRS is a chronic type 2 inflammatory sinus disease caused by fungal hypersensitivity, often leading to nasal polyps, congestion, and surgical interventions when standard treatments fail. Dupixent inhibits IL4 and IL13 signalling and is not an immunosuppressant.

The development programme for Dupixent has included over 60 clinical studies involving more than 10,000 patients

Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) and is approved in more than 60 countries for multiple type 2 inflammatory diseases.

This study represents the first positive phase 3 trial specifically in AFRS, providing evidence of Dupixent's potential to reduce disease symptoms and surgical risk.