Sanofi, Regeneron's Dupixent Hits Key Goals in Late-Stage Fungal Allergy Trial

By Adria Calatayud

Sanofi and Regeneron Pharmaceuticals said their jointly developed Dupixent anti-inflammatory blockbuster drug achieved primary and secondary goals in a late-stage study for allergic fungal rhinosinusitis.

The companies said Friday that the U.S. Food and Drug Administration recently accepted for priority review a supplemental biologics license application for Dupixent in the condition, an inflammatory disease caused by an allergic hypersensitivity to fungi and can lead to nasal polyps, nasal congestion, loss of smell, and other symptoms. A decision is expected by the end of February, the companies said.

If approved, this would mark the ninth indication for which Dupixent gets FDA authorization, Sanofi and Regeneron said.

The study--conducted in patients aged 6 years and older--showed significant improvements in signs and symptoms, including reductions in nasal congestion and nasal polyps compared to placebo, the companies said.

The drug's safety was generally consistent with the known safety profile in respiratory indications, they added.

Write to Adria Calatayud at [e-mail]

(END) Dow Jones Newswires

11-07-25 0852ET