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EU Approves Dupixent® as First-Ever Treatment for Eosinophilic Esophagitis in Young Children

Dupixent® (dupilumab) approved in the EU for treating eosinophilic esophagitis in children.

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  • Nov 06, 2024

  • Simantini Singh Deo

EU Approves Dupixent® as First-Ever Treatment for Eosinophilic Esophagitis in Young Children

Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the European Commission (EC) has granted approval for Dupixent® (dupilumab) as the first and only treatment available for eosinophilic esophagitis (EoE) in children as young as one year old. This new indication covers young patients aged 1 to 11 years, weighing at least 15 kg, who have not responded to or cannot tolerate standard therapies. With this expansion, Dupixent now addresses EoE across all age groups in the EU, building on previous approvals for adults and adolescents. Dupixent is similarly approved for young children with EoE in the U.S. and Canada.


Roberta Giodice, President at ESEO Italia, said in a statement, “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.”


George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent, also mentioned, “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.”


Houman Ashrafian, M.D., Ph.D., Executive Vice President, Head of Research and Development at Sanofi, stated “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 paediatric 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 supported by findings from the EoE KIDS Phase 3 trial, conducted in two parts (A and B), which evaluated Dupixent in children aged 1 to 11 with eosinophilic esophagitis (EoE). The study demonstrated that children's response to Dupixent was consistent with that observed in adult and adolescent populations already approved for treatment.


In Part A of the study, children who received a higher, weight-based dose of Dupixent (n=37) showed the following results at 16 weeks compared to those on placebo (n=34):


  • Primary endpoint: 68% of treated children achieved histological disease remission (≤6 eosinophils/high power field), compared to just 3% in the placebo group. This effect was maintained for up to a year in Part B.


  • Reduction in esophageal eosinophils: There was an 86% decrease in peak eosinophil count in treated children, versus a 21% increase in the placebo group.


  • Endoscopic and microscopic improvement: Reductions in both abnormal endoscopic findings and microscopic disease severity and extent were observed.


  • Symptom improvement: A nominally significant improvement was seen in the frequency and severity of EoE signs, along with fewer days showing any symptoms, as reported by caregivers.


Safety outcomes in the EoE KIDS trial aligned with the established safety profile of Dupixent in older patients with EoE. Common side effects included injection site reactions, conjunctivitis, joint pain, oral herpes, and increased eosinophils, with some additional reports of bruising at injection sites. In children aged 1 to 11, common adverse events (≥10%) seen more frequently with Dupixent in Part A included COVID-19, nausea, injection site pain, and headache. The long-term safety profile in Part B remained consistent with Part A findings.

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