FDA Approves Dupixent as First Treatment for Allergic Fungal Rhinosinusitis in Adults and Children

The FDA has approved Dupixent (dupilumab; Regeneron Pharmaceuticals and Sanofi) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery. The regulatory action, granted under Priority Review, marks the first FDA-approved therapy specifically indicated for AFRS and expands Dupixent’s indications in sino-nasal diseases beyond chronic rhinosinusitis with nasal polyps (CRSwNP).¹

Regulatory Decision Establishes First Approved Therapy for AFRS

“[AFRS] is a disease that can leave both children and adults with inflamed nasal passages, nasal polyps and thick mucus causing constant nasal congestion,” Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, 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.”¹

George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, noted that beyond reducing nasal signs and symptoms, Dupixent reduced the need for surgery or systemic corticosteroids and was associated with fewer patients experiencing bone erosion in the sinuses.

Dupixent Mechanism of Action in Type 2 Inflammation

• Dupixent, a human monoclonal antibody of the immunoglobulin G4 subclass, acts as an interleukin (IL)-4 receptor alpha antagonist.³
• Dupixent inhibits IL-4 and IL-13 signaling by specifically binding to the IL-4 receptor alpha subunit shared by the IL-4 and IL-13 receptor complexes.
• Dupixent inhibits IL-4 signaling through the type 1 receptor and both IL-4 and IL-13 signaling through the type 2 receptor.
• Through blocking the IL-4R alpha subunit, dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, such as the release of proinflammatory cytokines, chemokines, and immunoglobulin E.

AFRS is a chronic type 2 inflammatory disease and a subtype of chronic rhinosinusitis caused by allergic hypersensitivity to fungi. The condition can result in nasal polyps, nasal obstruction, thick mucus discharge, loss of smell, and, in severe cases, bone erosion and facial deformities.

Standard treatment has historically involved surgery and prolonged systemic corticosteroid use, with recurrence common.

LIBERTY-AFRS-AIMS Trial Design and Patient Population

• The randomized, double-blind, placebo-controlled Phase III LIBERTY-AFRS-AIMS trial enrolled 62 adults and children aged 6 years and older with AFRS.
• Patients were randomly assigned to receive age- and weight-based Dupixent (200 mg or 300 mg every two or four weeks; n=33) or placebo (n=29) over 52 weeks.
• The primary endpoint was change from baseline in sinus opacification assessed by computed tomography using the Lund-Mackay score at week 52.
• Secondary endpoints included changes in nasal congestion, nasal polyp score, loss of smell, and need for systemic corticosteroids or surgery.

Sinus Opacification and Symptom Outcomes

• Sinus opacification scores improved by 50% with Dupixent versus 10% with placebo at week 52, representing a 7.36-point placebo-corrected reduction (p<0.0001).
• Significant reductions in sinus opacification were also observed at week 24 (p<0.0001).
• Patient-reported nasal congestion improved by 67% versus 25% at week 24 and by 81% versus 11% at Week 52 (p<0.0001 at both time points).
• Nasal polyp size decreased by 61% versus 15% at week 24 and by 63% versus 4% at Week 52 (p<0.0001).
• Loss of smell improved by 67% versus 19% at Week 24 (p<0.0001).

Reduction in Surgery and Corticosteroid Use

• Dupixent lowered the risk of systemic corticosteroid use and/or need for surgery by 92% over 52 weeks (p=0.0010).
• Three percent of patients receiving Dupixent required systemic corticosteroids and none required surgery, compared with 31% and 7%, respectively, in the placebo group.

Dupixent Safety Profile

• The safety profile in LIBERTY-AFRS-AIMS was consistent with the known safety profile of Dupixent in CRSwNP, with no new safety signals identified.
• In pooled CRSwNP data, the most common adverse events (≥1%) more frequently observed with Dupixent versus placebo included injection site reactions, conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache.

Dupixent is administered every two weeks in adults with AFRS and in pediatric patients based on body weight. The therapy is intended for use under healthcare professional guidance and may be administered in clinical settings or at home following appropriate training.

This approval represents the ninth FDA-approved indication for Dupixent and further expands its role across chronic diseases driven by type 2 inflammation.

References

1. Dupixent® (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS). News release. Regeneron. February 24, 2026. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-medicine-allergic

2. Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI). ClinicalTrials.gov. Updated December 22, 2025. Accessed February 25, 2026. https://clinicaltrials.gov/study/nct04684524

3. Bhatt S et al. Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. N Engl J Med. 2024;390:2274-2283. DOI: 10.1056/NEJMoa2401304. VOL. 390 NO. 24. June 27, 2024.