Fri Sep 20 11:45:00 UTC 2024: ## Dupixent Recommended for Young Children with Eosinophilic Esophagitis in Europe

**TARRYTOWN, NY and PARIS, Sept. 20, 2024** – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced today that the European Medicines Agency (EMA) has recommended approval of Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children aged 1 to 11 years. This recommendation, if approved by the European Commission, would make Dupixent the first and only medicine indicated for EoE in this age group in the EU.

The positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is based on a Phase 3 trial (EoE KIDS) conducted in children with EoE. The trial demonstrated that a significantly greater proportion of children receiving Dupixent achieved histological remission at week 16, compared to placebo, with results sustained for up to one year. Furthermore, caregivers reported improvements in the frequency and severity of EoE signs, and fewer days with EoE symptoms, in children treated with Dupixent.

The safety profile of Dupixent in children was generally consistent with the known safety profile in adults and adolescents with EoE. The most common side effects observed in children were COVID-19, nausea, injection site pain and headache.

EoE is a chronic inflammatory disease that affects the esophagus, impacting a child’s ability to eat and potentially causing vomiting, abdominal pain, and difficulty swallowing. The current treatment options are often inadequate, making this potential treatment a significant advancement for children suffering from this debilitating condition.

The use of Dupixent in children aged 1 to 11 years with EoE is currently under investigation and not yet approved in the EU. The European Commission is expected to make a final decision on approval in the coming months.

Dupixent, a fully human monoclonal antibody, is already approved in the EU for certain adults and adolescents with EoE, as well as for a range of other inflammatory conditions.

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