Sanofi and Regeneron's Dupixent (dupilumab) has received approval from the European Commission (EC) for the treatment of eosinophilic esophagitis (EoE) in children aged one to 11 years, weighing at least 15kg. This approval marks a significant advancement in the treatment landscape for this patient population, providing the first and only EU-approved medicine for young children with EoE.
Clinical Trial Data
The EC's decision was supported by data from the Phase 3 EoE KIDS trial, which demonstrated compelling efficacy and safety results. In this trial, 68% of children aged one to 11 years who received Dupixent achieved histological disease remission at week 16, compared to only 3% in the placebo group. These positive outcomes were sustained for up to one year, underscoring the durability of the treatment effect.
Dupixent also led to an 86% reduction in peak oesophageal intraepithelial eosinophil count from baseline, compared to a 21% increase in the placebo group. Furthermore, the treatment resulted in reductions in abnormal endoscopic findings, as well as improvements in overall disease severity and extent. Improvements in the frequency and severity of EoE signs and symptoms were also observed in Dupixent-treated patients.
The safety profile of Dupixent in this younger population was generally consistent with the known safety profile of the drug in adult and adolescent patients.
Mechanism of Action
Dupixent is designed to inhibit the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. These pathways have been shown to be key drivers of type 2 inflammation, which plays a significant role in multiple related diseases, including EoE.
Expert Commentary
Houman Ashrafian, executive vice president, head of research and development at Sanofi, stated, "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 EoE, Dupixent has the potential to give these young children a better chance to thrive."
George Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, added, "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."
