EMA Approves Dupixent as First-Ever Treatment for Young Children with Eosinophilic Esophagitis in the EU

EMA Approves Dupixent as First-Ever Treatment for Young Children with Eosinophilic Esophagitis in the EU

(IN BRIEF) The European Medicines Agency has approved Dupixent as the first treatment for eosinophilic esophagitis (EoE) in young children aged one to 11, marking a significant step in managing this condition in a critical developmental phase. The approval is based on phase 3 trial data showing Dupixent’s effectiveness in achieving sustained disease remission and improving symptoms, offering new hope for children who struggle with eating due to EoE. This decision expands Dupixent’s availability, which is already approved for young EoE patients in the U.S. and Canada.

(PRESS RELEASE) PARIS, 6-Nov-2024 — /EuropaWire/ — The European Medicines Agency has granted approval for Dupixent (dupilumab) as the first and only medication available in the EU to treat eosinophilic esophagitis (EoE) in children as young as one year old. This landmark decision opens a new treatment path for children between one and 11 years of age, weighing at least 15 kg, who have not responded to conventional therapies or are ineligible for them. This EU approval extends the previous indication for Dupixent in adults and adolescents with EoE and follows approvals in the U.S. and Canada for the same age group.

Dupixent’s approval is founded on promising data from the phase 3 EoE KIDS trial, which demonstrated that young children receiving Dupixent showed substantial disease remission after 16 weeks, with results maintained for up to a year. In the study, 68% of children on Dupixent achieved histological disease remission compared to 3% on placebo, along with significant reductions in eosinophil counts, endoscopic abnormalities, and severity of symptoms. The study also highlighted Dupixent’s safety profile, which aligns with the safety data seen in older EoE populations.

This treatment offers new hope for young patients with EoE, many of whom struggle with essential nutrition and growth due to the disease’s impact on their ability to eat. According to Dr. Houman Ashrafian, Sanofi’s Head of R&D, “This approval provides a vital new option for pediatric patients who previously lacked targeted therapies, offering these children a better chance to thrive.”

The study data also confirm Dupixent’s ability to improve quality of life for children and their families, who often rely on restrictive diets with limited effectiveness. Dr. George Yancopoulos of Regeneron emphasized, “This approval brings Dupixent’s proven safety and efficacy to a vulnerable young population and has the potential to transform their standard of care.”

For further information on Dupixent, visit www.infineon.com/aurixTC4x.

About EoE
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
The EoE 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.

About Dupixent
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.

About Regeneron
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.

About Sanofi
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

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SOURCE: Sanofi