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FDA Approves Drug for Adult and Pediatric Patients Aged 6 and Older with Allergic Fungal Rhinosinusitis

The FDA has granted approval for Dupixent (dupilumab) to treat allergic fungal rhinosinusitis (AFRS) in adults and children six years and older, marking the first indication for this rare sinus disease. The approval follows a 52‑week trial that demonstrated significant improvements in CT imaging, nasal polyp size, congestion, and sense of smell, while also reducing the need for systemic steroids and sinus surgery. Dupilumab’s safety profile in AFRS matched its established record in chronic rhinosinusitis with nasal polyps. The drug received priority review designation for this indication.