Paris and Tarrytown, NY — November 7, 2025 — Leads & Copy — A pivotal Phase 3 study of Sanofi and Regeneron’s Dupixent (dupilumab) in adults and children aged 6 years and older with allergic fungal rhinosinusitis (AFRS) met all primary and secondary endpoints, demonstrating significant improvements in signs and symptoms of the disease, according to a press release issued by Regeneron.
The LIBERTY-AFRS-AIMS study (NCT04684524) showed significant reductions in sinus opacification, nasal congestion, and nasal polyps compared to placebo. The results were presented at the American College of Allergy, Asthma and Immunology (ACAAI) 2025 Annual Scientific Meeting in Orlando, FL.
The U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Dupixent with priority review. The target action date is February 28, 2026. If approved, Dupixent would be the first and only medicine specifically indicated for AFRS and its ninth FDA-approved indication.
AFRS is a chronic type 2 inflammatory disease of the sinuses caused by an intense allergic hypersensitivity to fungi, most usually aspergillus. It primarily affects people living in warm, humid climates where fungal spores are common in the environment. It can lead to nasal polyps, nasal congestion, loss of smell, thick mucus discharge, poor health-related quality of life, bone loss around the sinus cavities, and facial deformities. AFRS is a unique and distinct type of chronic rhinosinusitis with nasal polyps that can be harder to treat because it does not respond well to available options. Current standard-of-care treatment is surgery and prolonged courses of systemic steroids; however, disease recurrence can occur.
Dr. Amber U. Luong from the McGovern Medical School of the University of Texas Health Science Center at Houston, and lead investigator of the study noted, “This study is significant as it is the first positive phase 3 study for an investigational treatment specifically for AFRS. The ability of Dupixent to alleviate the hallmark signs and symptoms of AFRS, and to reduce the risk for surgery and corticosteroids by 92%, provide the strongest evidence to date that IL4 and IL13 are key drivers of the type 2 inflammation leading to this disease, as they seem to be for multiple other type 2 inflammatory diseases.”
The LIBERTY-AFRS-AIMS study randomized 62 adults and children to receive Dupixent (200 mg or 300 mg; n=33) or placebo (n=29). Key findings included:
- Sinus opacification scores improved by 50.0% in the Dupixent group versus 9.8% in the placebo group at 52 weeks (p<0.0001).
- Patient-reported nasal congestion/obstruction improved by 66.7% in the Dupixent group versus 25.3% in the placebo group at 24 weeks (p<0.0001), continuing to 80.6% versus 11.1% at 52 weeks (p<0.0001).
- Nasal polyp size reduced by 60.8% in the Dupixent group compared to 15.2% in the placebo group at 24 weeks (p<0.0001), continuing to 62.5% versus 3.6% at 52 weeks (p<0.0001).
- A 92% lower risk of systemic corticosteroid use and/or need for surgery in the Dupixent group compared to placebo (p=0.0010) over 52 weeks.
Adverse events were generally consistent with Dupixent’s known safety profile. Overall rates of adverse events (AEs) were 70% with Dupixent and 79% with placebo. Serious AEs were reported in 0% and 7% of patients treated with Dupixent and placebo, respectively.
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. It has received regulatory approvals in more than 60 countries for various indications.
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement and has been studied across more than 60 clinical studies.
Contacts:
Sanofi Media Relations:
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com
Sanofi Investor Relations:
Thomas Kudsk Larsen |+44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com
Regeneron Media Relations:
Sharon Chen | +1 914-847-1546| sharon.chen@regeneron.com
Regeneron Investor Relations:
Mark Hudson | +1 914-847-3482 | mark.hudson@regeneron.com
Source: Regeneron
