Full Press Release Details
Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitis
Paris and Tarrytown, NY, November 6, 2024. The European Medicines
Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled
by, intolerant to, or who are not candidates for conventional medicinal therapy. This expands the initial approval in the European
Union (EU) for EoE in adults and adolescents and makes Dupixent the first and only medicine indicated to treat these young patients. Dupixent is also approved in this young age group in the US and Canada.
President, ESEO Italia
Young children with eosinophilic esophagitis are at the beginning of their life-long journey with a disease
that challenges their ability to eat. Parents of these children have often relied on restrictive diets that do not specifically address the disease and can stunt their growth at a critical time in development that could impact them for years to
come. We are pleased that research continues and offers new treatment options to improve the quality of their care.
Houman Ashrafian, MD, PhD
Executive Vice President, Head of Research and Development, Sanofi
Up to half of all children in the EU with eosinophilic esophagitis remain uncontrolled despite existing standard of care
treatment options, and, as a result, many of these young patients struggle to maintain weight due to serious symptoms such as difficulty swallowing and vomiting. This milestone provides an important new treatment for pediatric patients who were
previously without options specifically approved for their disease. With this novel approach to addressing an underlying cause of eosinophilic esophagitis, Dupixent has the potential to give these young children a better chance to thrive.
The approval is based on the two-part (Part A and B)
EoE KIDS phase 3 study in children aged one to 11 years, which established a bridge showing the response to Dupixent in children with
EoE is similar to that of the approved adult and adolescent populations. In Part A, children who received a higher dose of Dupixent (n=37) based on a weight-based dosing regimen experienced the following outcomes, compared to placebo (n=34) at 16
The safety results in the EoE KIDS study were generally consistent with the known
safety profile of Dupixent in adolescents and adults with EoE. The most common adverse reactions for Dupixent overall are injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes and eosinophilia. In addition, the
adverse reaction of injection site bruising was reported in EoE. In patients aged one to 11 years, adverse events more commonly observed with Dupixent ( 10%) in either weight-based dosing
regimen compared to placebo during Part A were COVID-19, nausea, injection site pain, and headache. The long-term safety profile of Dupixent evaluated in Part B was similar to that observed during Part A.
George D. Yancopoulos, M.D., Ph.D.
Board co-Chair, President, and Chief Scientific Officer at Regeneron
Eosinophilic esophagitis presents a unique challenge in young children, who struggle with their basic ability to eat during a
time in their lives where proper nutrition is essential for growth and development. This approval will bring the proven efficacy and demonstrated safety profile of Dupixent to this vulnerable, young population that has already been established in
older EoE patients and has the potential to transform the standard of care for children with EoE who previously had no therapies specifically approved for them.
EoE is a chronic, progressive disease associated with type-2 inflammation that is thought to be responsible for damaging the esophagus and impairing its function. Diagnosis is difficult, as symptoms can be mistaken for other conditions leading to delays in diagnosis.
EoE can severely impact a child s ability to eat and may also cause vomiting, abdominal pain, difficulty swallowing, decreased appetite, and challenges thriving. Continuous management of EoE may be needed to reduce the risk of complications and
disease progression.
About the Dupixent pediatric EoE study
KIDS phase 3 study was a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Dupixent in children aged one to 11 years with EoE. Part A enrolled 71 patients and evaluated Dupixent at a weight-based dose regimen,
compared to placebo, for 16 weeks. Part B was a 36-week extended active treatment period in which eligible children from Part A in the Dupixent group continued treatment, while those in the placebo group
switched to Dupixent. Patients included in this trial were previously treated and did not respond to conventional medicinal therapies, including proton pump inhibitors and/or swallowed topical corticosteroids.
The primary endpoint was histologic remission at 16 weeks, and secondary endpoints included assessments of endoscopic and histopathologic measures of the severity of
disease along with caregiver-reported clinical signs and symptoms of EoE. The 108-week open-label extension period (Part C) to evaluate longer-term outcomes was recently completed.
Results from the study were published in The New
England Journal of Medicine.
Dupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In patients aged one to 11 years with EoE,
Dupixent is administered every other week (200 mg for children 15 to <30 kg, 300 mg for children 30 to <40 kg) or every week (300
mg for children 40 kg), based on weight. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home administered by a caregiver after
training by a healthcare professional.
Dupixent 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, EoE, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different
age populations. More than 1,000,000 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.
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 bullous pemphigoid. 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
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
For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram,
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people s lives. Our team, across the world, is
dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting
sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Sanofi Media Relations
| + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | + 1 215 432 0234
Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | + 1 516 521 2929 |
Sanofi Investor Relations
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Del pine | + 33 6 73 69 36 93
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 |
| + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Ch telet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Regeneron Media Relations
Hannah Kwagh | +1 914-847-6314| hannah.kwagh@regeneron.com
Regeneron Investor Relations
914-847-3482 | mark.hudson@regeneron.com
Sanofi forward-looking statements
This press release 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 pandemics or other 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, 2023. 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