FDA Approves Dupilumab for Allergic Fungal Rhinosinusitis

The FDA today approved dupilumab (Dupixent; Regeneron/Sanofi) for the treatment of allergic fungal rhinosinusitis (AFRS) in adults and children 6 years and older who have a history of sinonasal surgery, according to a press release.¹ Dupilumab’s approval for AFRS makes it the first and only medicine specifically approved for the condition and the drug's ninth FDA approval.

The approval is supported by data from the phase 3 LIBERTY-AFRS-AIMS trial, a randomized, double-blind, placebo-controlled study in 62 adults and children with AFRS. Patients received either an age- and weight-based dose of dupilumab or placebo over 52 weeks.

AFRS is a chronic type 2 inflammatory disease driven by an intense allergic hypersensitivity to environmental fungi. It predominantly affects people in warm, humid climates where fungal spores are prevalent and is marked by nasal polyps, severe congestion, loss of smell, and thick mucus discharge. In more serious cases, patients can experience bone erosion around the sinus cavities and facial deformities. Even after surgery, recurrence is common, leaving patients caught in a cycle of repeated procedures and steroid exposure.

In the LIBERTY-AFRS-AIMS trial, dupilumab reduced sinus opacification scores (a CT-based measure of disease extent and the trial’s primary end point) by 50% at week 52, compared with 10% with a placebo (P < .0001). Dupilumab also demonstrated significant benefits for secondary end points: patient-reported nasal congestion improved 81% vs 11% by week 52, and nasal polyp scores fell 63% vs 4%.

Most notably from a real-world treatment burden standpoint, dupilumab was associated with a 92% reduction in the risk of needing systemic corticosteroids or surgery over the 52-week period. Just 3% of patients on dupilumab received systemic corticosteroids during the trial, compared with 31% of those on placebo. Additionally, none of the participants in the dupilumab group required surgery, compared with 7% on placebo.

Loss of smell—one of the more debilitating symptoms of AFRS—also improved significantly, with patient-reported reductions of 67% with dupilumab vs 19% with placebo at week 24.

The safety profile was consistent with dupilumab's established profile in chronic rhinosinusitis with nasal polyps. Common adverse reactions include injection site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache.

"Before [dupilumab], people living with allergic fungal rhinosinusitis had to rely on treatments that left them potentially vulnerable to regrowth of nasal polyps and thick mucus that could rob them of their sense of smell," Alyssa Johnsen, MD, PhD, global therapeutic area head of immunology development at Sanofi, said in a statement.¹ “As the first medicine approved specifically for AFRS, [dupilumab] has been proven to lessen multiple signs and symptoms of disease, help break the cycle of recurrence, and reduce the risk for subsequent surgeries and corticosteroids by 92%. We look forward to working with regulators in other countries to bring this innovative option to more patients in need.”

Dupilumab works by blocking the signaling of IL-4 and IL-13 and is not an immunosuppressant. In adults with AFRS, the approved dose is 300 mg every 2 weeks; pediatric dosing is weight-based.

“With this approval, Dupixent once again demonstrates its value in advancing the treatment landscape for a chronic type 2 inflammatory disease with high unmet need,” George D. Yancopoulos, MD, PhD, board cochair, president, and chief scientific officer at Regeneron, and a principal inventor of dupilumab, said in a statement.¹ “Beyond reducing nasal signs and symptoms, [dupilumab] reduced the need for surgery or systemic corticosteroids with fewer patients having bone erosion in the sinuses. These results underscore its potential to establish a new standard of care for people living with AFRS. This ninth FDA approval for [dupilumab], the most widely used innovative branded antibody medicine, strengthens the established efficacy and body of evidence that IL-4 and IL-13 are major drivers of type 2 inflammation across many chronic diseases.”

Reference

Dupixent (dupilumab) is approved in the U.S. as the first and only medicine for allergic fungal rhinosinusitis (AFRS). News release. Regeneron. February 24, 2026. Accessed February 24, 2026. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-medicine-allergic