FDA Approves Dupilumab for AFRS in Patients Aged ≥ 6 Years With Prior Surgery

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) for the treatment of allergic fungal rhinosinusitis (AFRS) in adults and pediatric patients aged ≥ 6 years with a history of sinonasal surgery.¹ The decision, announced by Sanofi and Regeneron on February 24, 2026, marks the first FDA-approved therapy specifically indicated for AFRS, a subtype of chronic rhinosinusitis characterized by type 2 inflammation and high postsurgical recurrence rates.

“Before Dupixent, 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,” said Alyssa Johnsen, MD, PhD, global therapeutic area head of immunology development at Sanofi, in a statement.¹ “As the first medicine approved specifically for AFRS, Dupixent 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.”

AFRS is typically managed with functional endoscopic sinus surgery and prolonged systemic corticosteroid therapy, yet recurrence is common, and repeated steroids are frequently required.² The availability of a biologic agent targeting type 2 inflammatory pathways introduces a potential steroid-sparing option in a disease with limited pharmacologic alternatives.

The approval was supported by data from the phase 3 LIBERTY-AFRS-AIMS trial, a randomized, double-blind, placebo-controlled study evaluating dupilumab in 62 adults and children aged ≥6 years with AFRS and prior sinonasal surgery.³ Patients were randomized to weight-based dupilumab (200 mg or 300 mg every 2 or 4 weeks) or placebo for 52 weeks.

The primary endpoint, change from baseline in sinus opacification assessed by the Lund-Mackay (LMK) computed tomography score, demonstrated a statistically significant improvement at week 52. Dupilumab-treated patients experienced a 50% improvement compared with 10% in the placebo group (placebo-corrected reduction 7.36 points; P <.0001).1 Significant reductions were also observed at week 24.¹

Secondary endpoints included patient-reported nasal congestion, nasal polyp score assessed endoscopically, and loss of smell. At week 24, nasal congestion improved by 67% in the dupilumab group versus 25% with placebo (placebo-corrected difference 0.87 points; P <.0001), with continued improvement through week 52.¹ Nasal polyp scores and patient-reported anosmia similarly favored dupilumab. Over 52 weeks, the risk of systemic corticosteroid use and need for surgery was reduced by 92% relative to placebo (P =.0010).¹

Safety findings in LIBERTY-AFRS-AIMS were reported as consistent with the established dupilumab safety profile.¹ In pooled CRSwNP trials, common adverse reactions occurring in ≥1% of dupilumab-treated patients and more frequently than placebo included injection site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache.¹ No new safety signals were identified in the AFRS study.

Dupilumab is a fully human monoclonal antibody that inhibits signaling of interleukin (IL)-4 and IL-13, cytokines central to type 2 inflammation.¹ The agent is already approved across multiple type 2 inflammatory diseases, including atopic dermatitis, asthma, eosinophilic esophagitis, and chronic rhinosinusitis with nasal polyps (CRSwNP).¹ In CRSwNP, phase 3 SINUS-24 and SINUS-52 trials demonstrated significant reductions in nasal polyp size, sinus opacification, and need for systemic corticosteroids or surgery, supporting its established role in sinonasal inflammatory disease.⁴

As with other dupilumab indications, long-term safety beyond 52 weeks in AFRS specifically will require post-marketing data. Key clinical questions include the durability of response after discontinuation, cost-effectiveness compared with repeated surgery, and optimal positioning relative to corticosteroid therapy in pediatric populations.

“Beyond reducing nasal signs and symptoms, Dupixent reduced the need for surgery or systemic corticosteroids with fewer patients having bone erosion in the sinuses,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, in a statement. “These results underscore its potential to establish a new standard of care for people living with AFRS. This ninth FDA approval for Dupixent, the most widely used innovative branded antibody medicine, strengthens the established efficacy and body of evidence that IL4 and IL13 are major drivers of type 2 inflammation across many chronic diseases.”

References

1. Sanofi and Regeneron. Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis. February 24, 2026. Accessed February 24, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-24-14-30-00-3243732

2. Roland LT, Damask C, Luong AU, et al. Allergic Fungal Rhinosinusitis Diagnosis, Management, Associated Conditions, Pathophysiology, and Future Directions: Summary of a Multidisciplinary Workshop. Int Forum Allergy Rhinol. 2025;15(6):626-641. doi:10.1002/alr.23582

3. ClinicalTrials.gov. Study to evaluate dupilumab in patients with allergic fungal rhinosinusitis (LIBERTY-AFRS-AIMS). NCT04684524. Updated 2024. https://clinicaltrials.gov/study/NCT04684524

4. Bachert C, Han JK, Desrosiers M, et al. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019;394(10209):1638-1650. doi:10.1016/S0140-6736(19)31881-1