The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of allergic fungal rhinosinusitis (AFRS) in both adults and children aged 6 years and older with a history of sino-nasal surgery. The application received Priority Review designation, which is granted for therapies that may provide significant improvements in the treatment of serious conditions. This approval expands the use of Dupixent in sino-nasal diseases, beyond chronic rhinosinusitis with nasal polyps, to include AFRS.
AFRS is a type 2 inflammatory chronic disease triggered by an allergic response to fungi. It is considered a distinct subtype of chronic rhinosinusitis and is more common in warm and humid climates where the fungal spores are prevalent. Clinical features may include persistent nasal congestion, thick discharge of mucus, nasal polyps, and a reduced sense of smell. In severe cases, bone erosion around the sinuses and facial deformities may occur, significantly affecting their quality of life.
According to Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA), AFRS may be debilitating in both children and adults, resulting in inflammation of the nasal passages and persistent congestion. He noted that, as the first therapy specifically indicated for AFRS, dupilumab offers new hope for patients aged six years and older with difficult-to-control symptoms. Historically, management treatment has primarily relied on surgery and prolonged courses of systemic corticosteroids.
The approval is based on the findings from the LIBERTY-AFRS-AIMS phase 3 study, which was a 52-week randomized, placebo-controlled, double-blind study involving 62 patients aged 6 years and older. Participants received age- and weight-based dosing of either Dupixent (200 mg or 300 mg) on every two (Q2W) or four (Q4W) weeks (n = 33) or placebo (n = 29). The primary endpoint at Week 52 demonstrated an increase in sinus opacification scores by 50% in the Dupixent group compared with 10% in the placebo group, corresponding to a 7.36-point placebo-corrected difference (p <0.0001). Significant improvement was also recorded at Week 24 (p <0.0001).
Patient-reported nasal congestion improved by 0.87 points (placebo-corrected), representing an 81% relative improvement at Week 52 compared to 11% in the placebo group (p = 0.0001). At Weeks 52 and 24, relative improvements were 67% and 25%, respectively.
At Week 24, reductions in nasal polyp size were found (61% vs. 15%; 2.36-point placebo-corrected reduction; p = 0.0001), and at Week 52, the reduction was 63% compared to 4% (2.77-point placebo-corrected reduction; p = 0.0001). Improvement in loss of smell was also reported, with a placebo-corrected reduction of 0.89 at Week 24 (p<0.0001).
Over 52 weeks, treatment was associated with a 92% reduction in the risk of systemic corticosteroid use and/or surgery (p=0.0010). Among participants receiving a placebo, 31% required systemic corticosteroids or surgery, compared with 3% in the dupilumab group.
The safety profile was consistent with that previously reported for dupilumab in chronic rhinosinusitis with nasal polyps. The most reported adverse reactions (>1 percent) with dupilumab were injection site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache.
According to George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron, the approval is the potential new standard of care for AFRS. He noted that this is the ninth FDA approval for dupilumab, which is already approved in more than 60 countries for various type 2 inflammatory conditions. Globally, more than 1.4 million patients have received treatment with dupilumab.
Reference: Sanofi. Sanofi and Regeneron’s Dupixent was approved in the US as the first and only medicine for allergic fungal rhinosinusitis. Published February 23, 2026. Accessed February 27, 2026. Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis
