The U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab) on February 24, 2026, as the first and only medicine specifically targeting allergic fungal rhinosinusitis (AFRS) in adults and pediatric patients aged six years and older with a history of sino-nasal surgery, according to announcements from Regeneron Pharmaceuticals and Sanofi.
The approval is based on a phase 3 study demonstrating that Dupixent significantly reduced nasal signs and symptoms and decreased the require for systemic corticosteroid use or further surgery compared to a placebo, the companies stated. AFRS is a chronic type 2 inflammatory disease of the sinuses characterized by an allergic reaction to fungi, often requiring surgical intervention, which is frequently followed by recurrence.
The FDA granted Dupixent priority review for the treatment of AFRS, a designation reserved for medications with the potential to offer substantial improvements in the treatment, diagnosis, or prevention of serious conditions. This expands Dupixent’s approved indications within sino-nasal diseases to include AFRS, alongside its existing approval for chronic rhinosinusitis with nasal polyps.
“Allergic fungal rhinosinusitis (AFRS) is a disease that can leave both children and adults with inflamed nasal passages, nasal polyps, and thick mucus causing constant nasal congestion. Some patients can also experience more serious complications like deterioration of bone around the sinuses and facial deformities,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA).
Dupixent is now approved in the U.S. To treat nine distinct diseases driven by type 2 inflammation, encompassing conditions affecting the sino-nasal passages, skin, gut, and respiratory systems, and impacting patients across a wide age range, from infants to the elderly.