Dupilumab Approved by FDA as First Targeted Therapy for Allergic Fungal Rhinosinusitis

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) for the treatment of adults and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery, according to Sanofi and Regeneron. The approval follows priority review and is supported by data from the phase 3 LIBERTY-AFRS-AIMS trial (NCT04684524).¹

AFRS is a chronic type 2 inflammatory disease of the sinuses caused by an allergic hypersensitivity to fungi. The condition is characterized by nasal polyps, thick mucus, nasal congestion, and loss of smell, and may lead to bone erosion around the sinus cavities and facial deformities. Standard treatment has typically included surgery and prolonged systemic corticosteroids, with high rates of post-operative recurrence.¹

The randomized, double-blind, placebo-controlled LIBERTY-AFRS-AIMS study enrolled 62 adults and children aged 6 years and older with AFRS. Participants were randomized to receive age- and weight-based dupilumab (200 mg or 300 mg every two weeks [Q2W] or 300 mg every four weeks [Q4W]; n=33) or placebo (n=29) for 52 weeks. More than 80% of participants had a history of type 2 comorbidities.^1,2

The primary endpoint—change from baseline in sinus opacification as assessed by computed tomography using the Lund-Mackay score—improved by 50% with dupilumab versus 10% with placebo at week 52 (7.36-point placebo-corrected reduction; P < .0001). Significant reductions in sinus opacification were also observed at week 24 (P < .0001).²

At week 24, patient-reported nasal congestion or obstruction improved by 67% with dupilumab versus 25% with placebo (0.87-point placebo-corrected reduction; P < .0001), with continued improvement at week 52 to 81% versus 11% (1.40-point placebo-corrected reduction; P < .0001). Nasal polyp size, assessed by endoscopy, was reduced by 61% versus 15% at week 24 (2.36-point placebo-corrected reduction; P < .0001), with sustained reductions of 63% versus 4% at week 52 (2.77-point placebo-corrected reduction; P < .0001).²

Patient-reported loss of smell decreased by 67% with dupilumab compared with 19% with placebo at week 24 (0.89-point placebo-corrected reduction; P < .0001).²

Over 52 weeks, dupilumab reduced the risk of systemic corticosteroid use and/or need for surgery by 92% (29% fewer proportion of patients; P=.0010). Three percent of patients receiving dupilumab required systemic corticosteroids and none underwent surgery, compared with 31% and 7%, respectively, in the placebo group.²

Safety findings were consistent with the known safety profile of dupilumab in chronic rhinosinusitis with nasal polyps. In pooled data from pivotal trials in adults with chronic rhinosinusitis with nasal polyps, the most common adverse reactions (≥1%) observed more frequently with dupilumab than placebo included injection-site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache.^1,2

“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,” Kenneth Mendez, President and CEO, Asthma and Allergy Foundation of America (AAFA), said in a press release. “As the first treatment specifically approved for AFRS, Dupixent offers the potential for relief to adults and children six years and older struggling with potentially debilitating symptoms.”²

“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 co-Chair, President and Chief Scientific Officer at Regeneron, said in a press release. “Beyond reducing nasal signs and symptoms, Dupixent 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.”²

Dupilumab is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling and is not an immunosuppressant. It is administered subcutaneously and is approved in more than 60 countries across multiple type 2 inflammatory diseases. This latest approval marks its ninth FDA indication in the US.^1,2

References:

1. FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis. News release. US Food and Drug Administration. February 25, 2026. Accessed February 25, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-adult-and-pediatric-patients-aged-6-and-older-allergic-fungal-rhinosinusitis
2. Dupixent® (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS). News release. Regeneron. February 24, 2026. Accessed February 25, 2026. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-medicine-allergic