FDA approves dupilumab for allergic fungal rhinosinusitis

Dupilumab (Dupixent; Sanofi) received FDA approval for managing allergic fungal rhinosinusitis (AFRS) in patients as young as 6 years on February 24, 2026.¹

This marks the first FDA approval for this condition, providing relief to patients with a history of sinonasal surgery. Its safety and efficacy were confirmed in a 52-week trial that included both adult and pediatric patients as young as 6 years with AFRS.

“Based on the trial results and the existing safety database for dupilumab's approved uses, the benefits outweigh the risks for treating AFRS in patients 6 years and older,” the FDA wrote.

Clinical trial results demonstrate significant benefit

Based on CT scan scores (Lund-Mackay score), a significant improvement in sinus opacification was found in patients receiving dupilumab vs placebo. Secondary measures were also significantly improved from dupilumab, including the following:

• Nasal polyp size
• Nasal congestion
• Sense of smell

These improvements led to a significant reduction in the need for systemic corticosteroids and sinus surgery during the 52-week period compared with placebo. Additionally, reduced sinus bone erosion was reported from dupilumab, highlighting significant benefits in endoscopic results, imaging findings, and patient-reported symptoms.

A similar safety profile for dupilumab was reported in patients with AFRS vs those with chronic rhinosinusitis with nasal polyps. These safety outcomes were consistent across clinical trials and the postmarket setting, and there were no safety concerns that outweighed the benefits of dupilumab.

Dupilumab’s efficacy in pediatric patients was based on adult AFRS data, as similar disease mechanisms have been reported across age groups. Drug levels also do not significantly differ at weight-adjusted doses.

Adverse effects and the need for treatment

The drug’s safety was identified in children in adolescents receiving dupilumab to manage other conditions. Common adverse effects included elevated white blood cell count, injection-site reactions, toothache, insomnia, joint pain, and gastritis.

Approximately 8% of individuals with chronic sinus inflammation and nasal polyps are impacted by AFRS, defined as a chronic sinus inflammation caused by an allergic reaction to fungi growing in the sinuses. The condition often begins in teenagers and young adults and is more common in warm and humid regions that support fungi growth.

A common symptom of AFRS is the development of a thick, sticky mucus. The condition can lead to severe adverse outcomes such as sinus expansion, surrounding bone erosion, and eye or brain impacts that may cause nerve damage, facial problems, and facial deformities. This highlights the need for effective treatment.

Prior pediatric evidence in eosinophilic esophagitis

Dupilumab’s use in treating allergic conditions in pediatric patients has been supported by prior research, including a trial evaluating its efficacy against eosinophilic esophagitis (EoE).² These data have been highlighted by Joshua Wechsler, MD, MSCI, medical director at Ann & Robert H. Lurie Children’s Hospital of Chicago, Illinois.

Participants included children aged 1 to less than 18 years. Those receiving dupilumab had significantly improved remission rates vs the placebo group, which were sustained or enhanced at week 52.

Six or fewer eos/hpf were reported in 85.7%, 56.5%, and 51.4% of patients in the dupilumab group aged 1 to younger than 6 years, 6 to younger than 12 years, and 12 to younger than 18 years, respectively. In the placebo group, these rates were 0%, 3.8%, and 5.7%, respectively.

“This really tells us that, over time, the end points that we look at for therapy—things like eosinophil count and endoscopic measures—remain improved and potentially may even get better over time,” said Wechsler.

References

1. FDA approves drug for adult and pediatric patients aged 6 and older with allergic fungal rhinosinusitis. News release. FDA. February 24, 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. Wechdler J. Dupilumab's continued efficacy in pediatric EoE patients, with Joshua Wechsler, MD. Contemporary Pediatrics. November 12, 2025. Accessed February 25, 2026. https://www.contemporarypediatrics.com/view/dupilumab-s-continued-efficacy-in-pediatric-eoe-patients-with-joshua-wechsler-md