FDA Alert

FDA Approves Dupilumab for Allergic Fungal Rhinosinusitis

Kate Young

Key Highlights

  • The FDA approved dupilumab for allergic fungal rhinosinusitis for adult and pediatric patients aged 6 years and older.
  • Supporting data shows that dupilumab improves sinus opacification, nasal polyp size, and nasal congestion.
  • According to the FDA, safety issues associated with dupilumab are not outweighed by the benefits

The FDA has approved dupilumab (Dupixent) for allergic fungal rhinosinusitis (AFRS) — a rare chronic sinus inflammation caused by an allergic reaction to fungi growing in the sinuses — for adult and pediatric patients aged 6 years and older with a history of sino-nasal surgery.1

According to the FDA, AFRS affects up to 8% of individuals with chronic sinus inflammation and nasal polyps and causes serious problems such as erosion of surrounding bone in up to 90% of patients if left untreated.1

This decision comes after researchers assessed safety and efficacy of the drug in a 52-week clinical trial of 62 adults and children randomized to receive either an age- and weight-based dose of dupilumab (200 mg or 300 mg; n = 33) or placebo (n = 29).2,3 Sinus opacification scores, measured via computed tomography scans, improved 50% in the treatment arm compared with 9.8% in the placebo group a 52 weeks (P < .0001). Patient-reported nasal congestion improved by 66.7% in the treatment group versus 25.3% in the placebo group at 24 week and by 52 weeks the groups showed continued improvement by 80.6% and 11.1% respectively (P < .0001).3 Nasal polyp size, which was assessed using endoscopy, was reduced by 60.8% in the treatment arm compared with 15.2% in the placebo group at week 24, continuing reduction of 62.5% and 3.6% at 52 weeks (P < .0001). The treatment group also demonstrated a 92% lower risk of systemic corticosteroid use or need of surgery in the treatment group versus 29.1% in the placebo group over the 52-week study period (P < .001).3

Common adverse events included COVID-19 (15% dupilumab; 14% placebo) and nosebleed 12% dupilumab; 4% placebo), with overall rates of adverse events at 70% with treatment and 79% with placebo.3 Other common side effects include injection-site reactions, eosinophilia, insomnia, toothache, gastritis, and joint pain.1 According to the FDA, safety issues associated with the treatment are not outweighed by the benefits.1

References

  1. U.S. Food and Drug Administration. FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis. FDA. Published 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. National Library of Medicine. Dupilumab in allergic fungal rhinosinusitis (AFRS) (LIBERTY-AFRS-AI). NIH. Published December 22, 2025. Accessed February 25, 2026. https://clinicaltrials.gov/study/NCT04684524.
  3. Sanofi. Press release: ACAAI: Sanofi and Regeneron’s Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review. Sanofi. Published Nov. 7, 2025. Accessed February 25, 2026. https://www.sanofi.com/en/media-room/press-releases/2025/2025-11-07-13-00-00-3183599.