Dupixent Approved in EU for Eosinophilic Esophagitis Treatment in Young Children
Key Insights
The EMA has approved Dupixent (dupilumab) for treating eosinophilic esophagitis (search) (EoE) in children aged 1 to 11 years, marking the first such approval in the EU.
The approval is based on the Phase 3 EoE KIDS trial, which demonstrated significant histological disease remission in 68% of patients receiving Dupixent versus 3% on placebo.
Dupixent, a monoclonal antibody inhibiting IL-4 (search) and IL-13 (search) pathways, showed an 86% reduction in esophageal eosinophil count and reduced disease severity.
The European Medicines Agency (EMA) has granted approval for Sanofi and Regeneron’s Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (search) (EoE) in children aged one to 11 years. This marks the first approved treatment for this condition in young children within the European Union (EU). The approval is applicable for children weighing at least 15kg who are inadequately managed by, intolerant to, or ineligible for existing medicinal therapies.
This decision broadens Dupixent’s initial EU approval, which previously included only adults and adolescents with EoE. The treatment is also authorized for the same age group in both the US and Canada. Dupixent, developed through a global collaboration agreement between Sanofi and Regeneron, is administered via subcutaneous injection.
Mechanism of Action
Dupixent is a fully human monoclonal antibody that inhibits the interleukin-4 (search) (IL-4 (search)) and interleukin-13 (search) (IL-13 (search)) pathways, both known drivers of type-2 inflammation involved in EoE and related conditions.
Clinical Trial Data
The EU approval for treating young children with EoE was informed by the results of the Phase 3 EoE KIDS clinical trial, which assessed Dupixent’s efficacy and safety in children aged one to 11 years. The study was divided into two parts to evaluate the treatment’s performance in young patients.
In Part A, children receiving weight-based doses of Dupixent showed favorable outcomes after 16 weeks, with 68% of patients achieving 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. Additional 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.
Expert Commentary
Regeneron board co-chair, president, and chief scientific officer George D. Yancopoulos stated, “Eosinophilic esophagitis (search) 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.”
Dupixent's Global Reach
Currently, Dupixent is approved in over 60 countries for various conditions, including atopic dermatitis (search), asthma (search), chronic rhinosinusitis with nasal polyps (search), and chronic obstructive pulmonary disease (search). In late September, the monoclonal antibody secured approval in both the US and China for the treatment of COPD (search).