Full Press Release Details
ACAAI: Sanofi and Regeneron's Dupixent pivotal study met all primary and secondary endpoints, reducing
signs and symptoms of allergic fungal rhinosinusitis; sBLA accepted for FDA priority review
Paris and Tarrytown, NY, November 7, 2025. Positive results from the pivotal LIBERTY-AFRS-AIMS phase
3 study (NCT04684524) evaluating the investigational use of Dupixent (dupilumab) in adults and children aged 6 years and older with
allergic fungal rhinosinusitis (AFRS) demonstrated significant improvements in signs and symptoms of disease across all primary and secondary endpoints, including reductions in sinus opacification, nasal congestion, and nasal polyps compared to
placebo. These are the first-ever positive phase 3 results specifically in AFRS and will be shared today at the American College of Allergy, Asthma and Immunology (ACAAI) 2025 Annual Scientific Meeting, Orlando, FL, US.
Recently, the US Food and Drug Administration (FDA) accepted for priority review the supplemental biologics license application (sBLA) for Dupixent in
adults and children aged 6 years and older with AFRS. Priority review is granted by the FDA to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or
prevention of serious conditions. If approved, AFRS would represent the ninth FDA-approved indication for Dupixent.
AFRS, a subtype of chronic rhinosinusitis, 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.
"People with allergic fungal rhinosinusitis live with persistent nasal obstruction, congestion, and polyps that can place a
great strain on their day-to-day lives. With limited treatment options, uncontrolled symptoms can progress to serious complications like the buildup of thick mucus that
may require surgery, bony erosion of the sinuses, and facial deformities," said Amber U. Luong, MD, PhD, FACS, Professor and Vice Chair for Academic Affairs in the Department of Otorhinolaryngology at the McGovern
Medical School of the University of Texas Health Science Center at Houston, US and lead investigator of the study. "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."
In the LIBERTY-AFRS-AIMS study, 62 adults and children aged 6 years and older with AFRS were
randomized to receive an age- and weight-based dose of Dupixent (200 mg or 300 mg; n=33) every two or four weeks or placebo (n=29). The differences for Dupixent compared to placebo were as follows:
The safety in the study was generally consistent with the known
safety profile of Dupixent in its approved respiratory indications. The overall rates of adverse events (AEs) were 70% with Dupixent and 79% with placebo. The most common treatment-emergent AEs (>10%) occurring more frequently in Dupixent
compared to placebo included COVID-19 (15% Dupixent, 14% placebo) and nosebleed (12% Dupixent, 4% placebo). Serious AEs were reported in 0% and 7% of patients treated with Dupixent and placebo, respectively.
Additionally, AEs leading to study treatment discontinuation were reported in 3% of Dupixent patients and 4% of placebo patients.
efficacy of Dupixent in AFRS have not been fully evaluated by any regulatory authority.
About LIBERTY-AFRS-AIMS
LIBERTY-AFRS-AIMS is a randomized, double-blind, placebo-controlled phase 3 study assessing the safety and efficacy of Dupixent in adults and children
aged 6 years and older with AFRS. During the 52-week study, patients received an age- and weight-based dose of Dupixent (300 mg every two weeks for adults and children
weighing 60 kg, 200 mg every two weeks for children weighing 30 kg to <60 kg, or 300 mg every four weeks for children weighing 15 kg to <30 kg) or placebo. More than 80% of patients had a history of type 2 comorbidities.
The primary endpoint assessed change from baseline in sinus opacification assessed by CT scans using
the Lund-Mackay score (LMK; scale: 0-24) at 52 weeks. Secondary endpoints assessed at 24 weeks included:
Secondary endpoints assessed at 52 weeks included:
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. The Dupixent development
program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and
often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or
more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and bullous
pemphigoid in different age populations. More than one million patients are being treated with Dupixent globally.
Dupilumab development program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more
than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin, lichen simplex
chronicus, and allergic fungal rhinosinusitis. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
Regeneron (NASDAQ: REGN) is a leading
biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine
has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases,
cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron pushes the boundaries of scientific discovery and accelerates drug
development using our proprietary technologies, such as VelociSuite , which produces optimized fully human antibodies and new classes of bispecific
antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center and pioneering genetic medicine platforms, enabling us to
identify innovative targets and complementary approaches to potentially treat or cure diseases.
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn,
Instagram, Facebook or X.
R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines
that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive
progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.
Sanofi Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 |
Berland | +1 215 432 0234 | evan.berland@sanofi.com
L o Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 |
Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
L a 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
Aliz Kaisserian | +33 6 47 04 12 11 |
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 |
Elgoutni | +1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Ch telet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 |
Regeneron Media Relations
| +1 914-847-1546| sharon.chen@regeneron.com
Regeneron Investor Relations
Mark Hudson | +1 914-847-3482 | mark.hudson@regeneron.com
Sanofi forward-looking statements
contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding
the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes",
"intends", "estimates", "plans", and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect
the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating
to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and
volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global
economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary
Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake
any obligation to update or revise any forward-looking information or statements.
All trademarks mentioned in this press release are the property of the Sanofi group except for
VelociSuite and Regeneron Genetics Center.
Regeneron Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of
Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect,"
"intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking