At a Glance:
- FDA approved Dupixent as first AFRS treatment for adults/children ≥6 years post-surgery (priority review).
- LIBERTY-AFRS-AIMS phase 3 (NCT04684524) in 62 patients.
- 50% sinus improvement, 81% congestion relief, 92% lower surgery/steroid risk vs placebo.
- Ninth U.S. approval; global submissions planned.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
The U.S. FDA has approved Sanofi–Regeneron’s Dupixent (dupilumab) for adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS) who have undergone sino-nasal surgery. This marks the first targeted therapy for AFRS, a challenging subtype of chronic rhinosinusitis driven by fungal hypersensitivity.
The FDA’s decision to evaluate Dupixent under priority review highlights its potential to address a serious type 2 inflammatory sinus condition marked by fungal hypersensitivity, nasal polyps, congestion, and frequent surgical recurrences.
Clinical Evidence
The approval of Dupixent stems from the phase 3 LIBERTY-AFRS-AIMS trial (NCT04684524), randomizing 62 patients aged 6+ to Dupixent (200/300 mg every 2-4 weeks, weight-based) or placebo. The full results are published in Annals of Allergy, Asthma and Immunology.
Dupixent demonstrated clear superiority over placebo across key measures of allergic fungal rhinosinusitis (AFRS) severity and treatment burden. The primary endpoint showed sinus opacification scores on CT scans improving by 50% with Dupixent compared to just 10% with placebo at Week 52, reflecting a significant 7.36-point placebo-corrected reduction (p<0.0001); this benefit was already evident at Week 24 (p<0.0001).
For patient-reported nasal congestion or obstruction, improvements reached 67% versus 25% at Week 24 (0.87-point placebo-corrected reduction; p<0.0001), advancing to 81% versus 11% by Week 52 (1.40-point reduction; p<0.0001).
Nasal polyp size, assessed by endoscopy, decreased by 61% versus 15% at Week 24 (2.36-point reduction; p<0.0001), with sustained 63% versus 4% reduction at Week 52 (2.77-point reduction; p<0.0001).
Patient-reported loss of smell improved by 67% versus 19% at Week 24 (0.89-point reduction; p<0.0001).
Notably, Dupixent reduced the risk of needing systemic corticosteroids or surgery by 92% over 52 weeks (3% or 0% of Dupixent patients versus 31% or 7% on placebo; p=0.0010), highlighting its role in breaking the cycle of recurrence and invasive interventions.
Safety aligned with Dupixent’s profile in chronic rhinosinusitis with nasal polyps (CRSwNP), with common events like injection site reactions and conjunctivitis.
Dosing and Mechanism
Dupixent, a fully human monoclonal antibody blocking IL-4 and IL-13 signaling, is given subcutaneously: 300 mg Q2W for adults/≥60 kg children; 200 mg Q2W for 30-<60 kg; 300 mg Q4W for 15-<30 kg. It can be self-administered at home after training, with adult supervision for younger patients.
George D. Yancopoulos, Regeneron’s President and Chief Scientific Officer, noted Dupixent’s role in advancing type 2 inflammation treatments with high unmet need.
Alyssa Johnsen from Sanofi emphasized breaking the recurrence cycle, reducing surgeries and corticosteroids while preserving smell.
Kenneth Mendez of the Asthma and Allergy Foundation called it a potential relief for debilitating symptoms like facial deformities.
Broader Impact and Access
This Dupixent’s ninth FDA approval for AFRS builds on its robust history, starting with atopic dermatitis in 2017 and expanding in 2025 to include chronic spontaneous urticaria (April), bullous pemphigoid (June), and COPD add-on (prior year but reinforced). Globally approved in 60+ countries for 9+ indications like asthma, CRSwNP, and prurigo nodularis, it treats 1.4+ million patients by targeting IL-4/IL-13 in type 2 inflammation.
In 2025, Dupixent earned the prestigious Prix Galien USA “Best Biotechnology Product” award for its pioneering impact on allergic/atopic diseases.
Sanofi and Regeneron offer the DUPIXENT MyWay program for US access support. Ongoing phase 3 studies explore further type 2 conditions like chronic pruritus.
What is Allergic Fungal Rhinosinusitis?
AFRS is a chronic sinus disease driven by allergic reactions to fungi, leading to inflamed passages, thick mucus, polyps, and potential bone erosion around sinuses. Patients often face constant congestion, loss of smell, and repeated surgeries, with prior treatments relying on systemic corticosteroids that carry long-term risks. Affecting both kids and adults, it creates a cycle of recurrence without targeted therapies until now.
Reference
Press Release: Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis, February 24, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-24-14-30-00-3243732
Dupixent® (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS), 24 February 2026, https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-medicine-allergic
Dupixent® (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS), February 24, 2026. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-medicine-allergic
Dupilumab in Allergic Fungal Rhinosinusitis (AFRS) (LIBERTY-AFRS-AI), ClinicalTrials.gov ID NCT04684524. https://clinicaltrials.gov/study/NCT04684524
Luong, A. et al., Dupilumab Efficacy in Adults and Children Aged 6 And Over with Allergic Fungal Rhinosinusitis (LIBERTY-AIMS), Annals of Allergy, Asthma & Immunology, Volume 135, Issue 5, S100 – S101. https://doi.org/10.1016/j.anai.2025.08.297
About Writer:
Sana Jamil Khan
She is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publication and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.