The FDA has granted priority review approval to Dupixent (dupilumab), developed by Sanofi and Regeneron, for treating adults and pediatric patients aged 6 and older with allergic fungal rhinosinusitis who have prior sinus surgery history. The approval makes Dupixent the first and only medicine specifically approved for this chronic fungal-triggered inflammatory condition of the sinuses.
Results from the Phase 3 LIBERTY-AFRS-AIMS study of 62 patients showed significant improvements across key measures at week 52: a 50% improvement in sinus opacification versus 10% for placebo, an 81% improvement in nasal congestion versus 11%, and a 63% reduction in nasal polyps versus 4%. The treatment also demonstrated a 92% risk reduction in the need for surgery or systemic corticosteroids.
Allergic fungal rhinosinusitis is characterized by recurrent polyp growth and severe nasal obstruction. This new indication further extends the reach of Dupixent, which has become one of the most widely prescribed biologic medicines across multiple inflammatory conditions.