FDA Approves Dupilumab (Dupixent®) for Allergic Fungal Rhinosinusitis in Children and Adults
Rosa Beale
Allergies
Summary
The FDA has approved dupilumab (Dupixent®), developed by Sanofi and Regeneron, for treating allergic fungal rhinosinusitis (AFRS) in adults and children aged 6 and older with a history of sinus surgery. The approval was granted under priority review based on Phase 3 clinical trial results (LIBERTY AFRS AIMS) that demonstrated significant reductions in nasal signs and symptoms. AFRS is a chronic inflammatory condition that can severely impact quality of life and may require multiple surgeries. This approval expands treatment options for patients with this challenging condition and represents an important advance in managing allergic sinus disease.
