On February 26, 2026, the U.S. Food and Drug Administration (FDA) approved Dupixent (generic name: dupilumab) for the treatment of allergic fungal rhinosinusitis (AFRS) in adult and pediatric patients aged 6 years and older who have undergone prior nasal and sinus surgery.

Dupixent was granted priority review designation by the FDA for this indication, as existing therapeutic options for allergic fungal rhinosinusitis have limited efficacy. The current standard of care for this condition is surgery combined with long-term systemic glucocorticoid therapy, yet disease recurrence remains relatively common.

This approval is based on the LIBERTY-AFRS-AIMS Phase 3 clinical trial: a total of 62 patients with allergic fungal rhinosinusitis were enrolled and randomized by age and body weight to receive either Dupixent (200 mg or 300 mg administered every 2 or 4 weeks; 33 patients) or placebo (29 patients).

Dr. George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron Pharmaceuticals, Inc., stated in a press release: “Dupixent not only relieves nasal signs and symptoms, but also reduces the need for surgery or systemic glucocorticoids and lowers the risk of sinus bone erosion in patients. These results confirm that this medicine has the potential to establish an entirely new standard of care for patients with allergic fungal rhinosinusitis.”

The marketing authorization for Dupixent for this indication has been awarded to Regeneron Pharmaceuticals, Inc.