• 27 Feb 2026
• Admin
• News Article

FDA Approves Dupixent for Allergic Fungal Rhinosinusitis

The US Food and Drug Administration has approved Dupixent (dupilumab) for adults and children aged six years and older with allergic fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.

The approval was granted under priority review, highlighting the therapy’s potential to significantly improve outcomes in a serious condition with limited treatment options.

A First-Ever Approval for AFRS

This decision marks an important milestone.

• Dupixent is the first treatment specifically approved for AFRS
• The indication expands Dupixent’s role in sino-nasal diseases
• It now includes AFRS alongside chronic rhinosinusitis with nasal polyps (CRSwNP)

AFRS is considered one of the most severe and difficult-to-treat subtypes of chronic rhinosinusitis.

Understanding the Burden of AFRS

Allergic fungal rhinosinusitis is a chronic type 2 inflammatory disease driven by an exaggerated immune response to environmental fungi.

Patients often experience:

• Persistent nasal congestion
• Nasal polyps
• Thick mucus discharge
• Loss of smell
• Poor quality of life

In severe cases, AFRS can lead to bone erosion around the sinuses and facial deformities.
The disease is more common in warm, humid climates, where fungal exposure is high.

Limitations of Current Treatment Options

Standard care for AFRS typically involves:

• Repeated sinus surgeries
• Long courses of systemic corticosteroids

However:

• Disease recurrence is common
• Steroid exposure carries long-term risks
• Many patients cycle through surgery and relapse

This has left a clear unmet medical need.

Phase 3 Data Supporting the Approval

The FDA approval is supported by results from the LIBERTY-AFRS-AIMS Phase 3 trial (NCT04684524).

Study overview

• Randomized, double-blind, placebo-controlled
• Included 62 adults and children (≥6 years)
• Evaluated Dupixent versus placebo over 52 weeks

Primary endpoint

• Sinus opacification on CT scans improved by 50% with Dupixent, compared to 10% with placebo at Week 52
• Results were statistically significant (p<0.0001)

Key Secondary Outcomes

Dupixent demonstrated consistent benefits across multiple clinical measures.

Nasal signs and symptoms

• Nasal congestion improved by 67% at Week 24 and 81% at Week 52
• Nasal polyp size reduced by over 60% by Week 24, with sustained benefit at one year

Sense of smell

• Loss of smell improved by 67%, compared with 19% on placebo

Treatment burden

• 92% reduction in risk of systemic steroid use or additional surgery
• Only 3% of Dupixent-treated patients required steroids
• No Dupixent-treated patients required surgery

Safety Profile

The safety results were consistent with Dupixent’s established profile in CRSwNP. Common adverse events included:

• Injection site reactions
• Conjunctivitis
• Arthralgia
• Eosinophilia
• Insomnia

No new safety signals were identified.

How Dupixent Works?

Dupixent is a fully human monoclonal antibody that inhibits signaling of IL-4 and IL-13, two central drivers of type 2 inflammation.

• It is not an immunosuppressant
• Targets the underlying inflammatory pathway
• Addresses disease drivers rather than symptoms alone

Industry Perspective

According to leadership at Sanofi, the approval represents a shift in how AFRS can be managed, moving beyond repeated surgery and steroid dependence.

Regeneron also highlighted that Dupixent reduced the need for surgery and systemic corticosteroids, while lowering the incidence of sinus bone erosion—supporting its potential to redefine standard of care.

Global Outlook for Dupixent

• Approved in more than 60 countries across multiple indications
• Used by over 1.4 million patients globally
• This marks the ninth FDA approval for Dupixent

Additional regulatory submissions for AFRS are planned in other regions.

The Bigger Picture

For patients with allergic fungal rhinosinusitis, treatment options have long been limited and invasive.

With FDA approval of Dupixent, clinicians now have a targeted, disease-modifying therapy that reduces symptoms, lowers recurrence, and minimizes the need for surgery—setting a new benchmark in AFRS care.