The European Medicines Agency (EMA) has granted approval for Sanofi and Regeneron’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years.
This marks the first time a treatment has been approved for this condition in young children within the European Union (EU). The approval applies to children who weigh at least 15kg and who are either inadequately managed by, intolerant to, or not eligible for existing medicinal therapies.
This decision extends Dupixent’s initial approval in the EU, which was previously restricted to adults and adolescents with EoE. The treatment is also authorised for the same age group in both the US and Canada.
Developed jointly by Sanofi and Regeneron under a global collaboration agreement, Dupixent is administered through a subcutaneous injection.
Dupixent is a fully human monoclonal antibody designed to inhibit the interleukin-4 (IL4) and interleukin-13 (IL13) pathways, which are known to drive type-2 inflammation involved in EoE and related conditions.
The EU approval for treating young children with EoE was based on results from the EoE KIDS phase 3 clinical trial, which evaluated Dupixent’s efficacy and safety in children aged one to 11 years.
The study was conducted in two parts to assess the treatment’s performance in young patients.
In Part A, children receiving weight-based doses of Dupixent showed favourable outcomes after 16 weeks, with 68% of patients reaching histological disease remission, compared to 3% in the placebo group. This level of remission was maintained for up to one year in Part B of the study.
Other significant findings included an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline, alongside reduced abnormal endoscopic findings and reduced disease severity at the microscopic level.
Regeneron board co-chair, president, and chief scientific officer George D. Yancopoulos said: “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.”
Currently, Dupixent is approved in over 60 countries for various conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and chronic obstructive pulmonary disease.
In late September, the monoclonal antibody secured approved in both the US and China for the treatment of COPD.
