Drug Update · Otolaryngology

FDA Approves Dupilumab for Allergic Fungal Rhinosinusitis: 50% vs 10% CT Improvement

August 11, 2026

Drug

Dupilumab (Dupixent)

Indication

Allergic fungal rhinosinusitis in patients aged 6 years and older with history of sino-nasal surgery

Approval date

02/23/2026

Primary endpoint result

50% vs 10% sinus opacification improvement at Week 52 (7.36-point placebo-corrected reduction; p<0.0001)

Trial

LIBERTY-AFRS-AIMS Phase 3 (n=62)

Adult dose (approved)

300 mg every 2 weeks subcutaneous

Clinical Perspective

This approval affects otolaryngologists, allergists, and other clinicians who manage adults and pediatric patients aged 6 years and older with AFRS who have a history of sino-nasal surgery, per the FDA-approved indication ^[1]^[2]. The LIBERTY-AFRS-AIMS Phase 3 data showing improvement in sinus opacification and nasal signs and symptoms versus placebo support use of dupilumab in this population ^[5]^[4]. How long patients with AFRS should remain on dupilumab to minimize postoperative recurrence remains an open clinical question?

Dr. Abhishek Malhotra, MBBS, MS (Otorhinolaryngology) · ENT

The FDA approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery, effective on the date of the FDA approval letter (02/23/2026) ^[2]. The approval was supported by the Phase 3 LIBERTY-AFRS-AIMS trial, in which dupilumab improved sinus opacification scores by 50% versus 10% with placebo at Week 52 (7.36-point placebo-corrected reduction; p<0.0001) ^[5]^[4].

Clinical Context

Dupilumab (Dupixent) is an interleukin-4 receptor alpha antagonist that inhibits IL-4 and IL-13 signaling; the mechanism and role of IL-4/IL-13 in type 2 inflammation are described in the prescribing information ^[6]. Dupixent is developed and marketed by Regeneron and Sanofi, and the new approval adds allergic fungal rhinosinusitis to its labeled indications for sino-nasal disease alongside chronic rhinosinusitis with nasal polyps ^[1]^[5]. The FDA reviewed a supplemental biologics license application under priority review and issued a supplemental approval letter expanding the label to include AFRS in patients aged 6 years and older with prior sino-nasal surgery ^[2]^[5]. Dosing for adults with AFRS in the approved labeling is 300 mg administered every 2 weeks by subcutaneous injection ^[1]^[3]. Clinicians should consult current prescribing information for full dosing guidance.

Key Findings

The LIBERTY-AFRS-AIMS Phase 3 trial showed dupilumab achieved a 50% improvement in sinus opacification scores versus 10% with placebo at Week 52 (7.36-point placebo-corrected reduction; p<0.0001) ^[5]^[4].
In the trial, patient-reported nasal congestion/obstruction improved by 67% versus 25% with placebo at Week 24 (0.87-point placebo-corrected reduction; p<0.0001) and by 81% versus 11% at Week 52 (1.40-point placebo-corrected reduction; p<0.0001) ^[4]^[5].
Nasal polyp size assessed by endoscopy was reduced by 61% versus 15% at Week 24 (2.36-point placebo-corrected reduction; p<0.0001) and by 63% versus 4% at Week 52 (2.77-point placebo-corrected reduction; p<0.0001) ^[4]^[5].
The randomized trial included 62 adults and children aged 6 years and older, with 33 randomized to dupilumab and 29 to placebo, using age- and weight-based dosing every two or four weeks ^[5]^[4].

Safety & Tolerability

Injection site reactions ^[1]^[3]
Eosinophilia ^[1]^[3]
Insomnia ^[1]^[3]
Toothache ^[1]^[3]
Gastritis ^[1]^[3]
Arthralgia ^[1]^[3]
Conjunctivitis ^[1]^[3]

Study Design

The approval is supported by the randomized, controlled Phase 3 LIBERTY-AFRS-AIMS trial (n=62), which randomized 33 patients to an age- and weight-based dupilumab regimen (200 mg or 300 mg Q2W or Q4W) and 29 to placebo; primary and key secondary endpoints included sinus opacification by CT and selected nasal signs and symptoms at Week 24 and Week 52 ^[5]^[4]. Clinicians should consult current prescribing information for full dosing guidance. The FDA issued a prior-approval supplemental BLA letter approving the new AFRS indication, effective on the date of the approval letter 02/23/2026 ^[2].

FAQ

Q1 What is Dupixent (Dupilumab) approved for?

Dupixent is approved for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery, according to the updated FDA labeling and approval letter. The approval expands Dupixent’s indications to include AFRS alongside its other approved sino-nasal and systemic type 2 inflammatory diseases.

Q2 How does dupilumab work?

Dupilumab is a human monoclonal antibody that binds the interleukin-4 receptor alpha (IL-4Rα) subunit, inhibiting signaling of IL-4 and IL-13 through Type I and Type II receptors. Blocking IL-4Rα reduces IL-4- and IL-13-mediated type 2 inflammatory responses that contribute to diseases including AFRS, as described in the prescribing information.

Q3 What is the recommended dose of Dupixent for AFRS?

The FDA prescribing information lists the recommended adult dosage for Allergic Fungal Rhinosinusitis as 300 mg given every 2 weeks by subcutaneous injection. Pediatric dosing for patients aged 6 to 17 years is weight- and age-based as specified in the labeling. Clinicians should consult current prescribing information for full dosing guidance.

Q4 What are the most common side effects?

Adverse reactions in the labeling include injection site reactions, eosinophilia, insomnia, toothache, gastritis, arthralgia, and conjunctivitis; the AFRS safety profile is noted as similar to that observed in chronic rhinosinusitis with nasal polyps. Clinicians and patients should review the full prescribing information for detailed safety, contraindications, and monitoring guidance.

Clinicians should consult current prescribing information for full dosing guidance.

FDA Approves Dupilumab for Allergic Fungal Rhinosinusitis: 50% vs 10% CT Improvement

Direct Clinical Takeaway & Evidence Summary

FDA Approves Dupilumab for Allergic Fungal Rhinosinusitis: 50% vs 10% CT Improvement

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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