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Sanofi and Regeneron's Dupixent approved in the US as the first and only
medicine for allergic fungal rhinosinusitis
Paris and Tarrytown, NY, February 24, 2026. The US Food and Drug Administration (FDA) has 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. The FDA evaluated Dupixent under priority review for the treatment of AFRS, which is reserved
for medicines that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. This approval expands our approved indications in sino-nasal diseases to now include AFRS, alongside chronic
rhinosinusitis with nasal polyps.
"Allergic fungal rhinosinusitis (AFRS) is a disease that can leave both
children and adults with inflamed nasal passages, nasal polyps, and thick mucus causing constant nasal congestion. Some patients can also experience more serious complications like deterioration of bone around the sinuses and facial
deformities," said Kenneth Mendez, President and CEO, Asthma and Allergy Foundation of America (AAFA). "As the first treatment specifically approved for AFRS, Dupixent offers the potential for relief to adults and
children six years and older struggling with potentially debilitating symptoms."
AFRS is a chronic type 2 inflammatory disease. It is a
specific subtype of chronic rhinosinusitis distinctly caused by an intense allergic hypersensitivity to fungi. 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, and patients can also experience bone loss around the sinus cavities and facial deformities. AFRS can be a severe and hard-to-treat form of chronic rhinosinusitis because it may not respond well to available options. Current standard-of-care
treatment is surgery and prolonged courses of systemic steroids; however, disease recurrence is not uncommon.
"Before Dupixent, people living with allergic fungal rhinosinusitis had to rely on treatments that left them
potentially vulnerable to regrowth of nasal polyps and thick mucus that could rob them of their sense of smell," said Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology Development at Sanofi. "As
the first medicine approved specifically for AFRS, Dupixent has been proven to lessen multiple signs and symptoms of disease, help break the cycle of recurrence, and reduce the risk for
subsequent surgeries and corticosteroids by 92%. We look forward to working with regulators in other countries to bring this innovative option to more patients in need."
The FDA approval is supported by the LIBERTY-AFRS-AIMS phase 3 study (clinical study identifier: NCT04684524), in which 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) every two (Q2W) or four weeks (Q4W) (n=33) or placebo (n=29). The differences for Dupixent compared to
placebo were as follows:
Primary endpoint: Sinus opacification scores (a measure of extent of sinus involvement by the disease as
assessed by computed tomography [CT] scans) improved by 50% versus 10% at Week 52 (7.36-point placebo-corrected reduction; p<0.0001); a significant reduction in sinus opacification scores was also observed
at Week 24 (p<0.0001).
Secondary endpoints:
The safety results in the LIBERTY-AFRS-AIMS study were similar to the known safety profile of Dupixent in CRSwNP. In pooled data from two pivotal CRSwNP
studies in adults, the most common adverse reactions ( 1%) in the US Prescribing Information more frequently observed in patients on Dupixent compared to placebo were injection site reactions,
conjunctivitis, arthralgia, gastritis, insomnia, eosinophilia, and toothache.
"With this approval,
Dupixent once again demonstrates its value in advancing the treatment landscape for a chronic type 2 inflammatory disease with high unmet need," said George D. Yancopoulos, MD, PhD, Board
co-Chair, President and Chief Scientific Officer at Regeneron. "Beyond reducing nasal signs and symptoms, Dupixent reduced the need for surgery or systemic corticosteroids with fewer patients having bone
erosion in the sinuses. These results underscore its potential to establish a new standard of care for people living with AFRS. This ninth FDA approval for Dupixent, the most widely used innovative branded antibody medicine, strengthens the
established efficacy and body of evidence that IL4 and IL13 are major drivers of type 2 inflammation across many chronic diseases."
Additional submissions are planned to other regulatory authorities around the world.
About LIBERTY-AFRS-AIMS
The LIBERTY-AFRS-AIMS phase 3 study
was a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of Dupixent in adults and children aged 6 years and older with AFRS. The 52-week study included an age- and weight-based dose of Dupixent (300 mg Q2W for adults and children weighing 60 kg, 200 mg Q2W for children weighing 30 kg to <60 kg, or 300 mg Q4W for children weighing 15 kg to <30 kg) or placebo. More than 80% of patients had a history of type 2
The primary endpoint assessed change from baseline in sinus opacification assessed by CT scans using the Lund-Mackay score (LMK;
scale: 0-24) at Week 52. Secondary endpoints assessed at Week 24 included:
Some secondary endpoints were also assessed at Week 52 in addition to proportion of patients requiring surgery or systemic
corticosteroids during the treatment period. Proportion of patients with bone erosion in the sinuses as evaluated by CT scans was a tertiary endpoint assessed at Week 52.
Dupixent (dupilumab) is an injection
administered under the skin (subcutaneous injection) at different injection sites. In adults with AFRS, Dupixent 300 mg is administered every two weeks. In children with AFRS, Dupixent is administered based on weight: 300 mg every two weeks for 60 kg, 200 mg every two weeks for 30 kg to <60 kg, or 300 mg every four weeks for 15
kg to <30 kg. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. In children aged 12 to 17 years, Dupixent should be administered under
the supervision of an adult. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home.
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.
Sanofi and Regeneron are committed to helping patients in the US who
are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com.
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, bullous pemphigoid, and AFRS in different age populations. More than 1.4 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 12,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to 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 and lichen simplex chronicus. 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
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
is an 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
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