EMA Approves Dupixent for Eosinophilic Esophagitis in Young Children
Key Insights
The EMA has approved Dupixent (dupilumab) for treating eosinophilic esophagitis (search) (EoE) in children aged 1-11 years, weighing at least 15kg, who have not responded well to conventional treatments.
This approval expands Dupixent's use in the EU, following its initial approval for adolescents and adults with EoE in January 2023, and mirrors approvals in Canada and the US.
The decision was based on the EoE KIDS Phase III trial, which demonstrated Dupixent's efficacy and safety, showing 68% of patients achieving histological disease remission compared to 3% in the placebo group after 16 weeks.
The European Medicines Agency (EMA) has approved Dupixent (dupilumab), developed by Sanofi and Regeneron, for the treatment of eosinophilic esophagitis (search) (EoE) in children aged one to 11 years. This approval marks a significant advancement for young patients who have not responded adequately to traditional medicinal therapies.
The approval extends Dupixent's availability to a younger population, specifically those weighing a minimum of 15kg. It builds upon the initial European Union (EU) approval granted in January 2023 for treating EoE in adolescents and adults. Dupixent is now the first and only medication approved for this young patient demographic in Europe, with similar approvals already in place in Canada and the US.
The EMA's decision is rooted in the positive outcomes of the EoE KIDS, a two-part, randomised, double-blind, placebo-controlled Phase III trial. The study evaluated the efficacy and safety of Dupixent in children with EoE. Part A of the study included 71 children who received a weight-based dosing regimen of Dupixent. After 16 weeks, 68% of patients treated with Dupixent achieved histological disease remission, the primary endpoint, compared to only 3% in the placebo group. These positive outcomes were sustained for up to one year in Part B of the study. Part C, a 108-week open-label extension period designed to assess longer-term outcomes, was recently completed.
"Up to half of all children in the EU with eosinophilic esophagitis (search) 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 vomiting and difficulty swallowing," said Houman Ashrafian, Sanofi's Head of Research and Development. "This milestone provides an important new treatment for paediatric patients who were previously without options specifically approved for their disease."
Mechanism of Action
Dupixent is a fully human monoclonal antibody developed using Regeneron's VelocImmune technology. It functions by blocking the interleukin-4 (search) (IL-4) and interleukin-13 (search) (IL-13) signaling pathways, which are key drivers of the inflammation associated with eosinophilic esophagitis (search).
Regeneron and Sanofi are co-developing dupilumab under a global collaboration agreement.