Press release: CHMP recommends EU approval of Dupixent for the treatment of eosinophilic esophagitis in children aged one year and above Page 1

CHMP recommends Dupixent for EU approval for the treatment of eosinophilic esophagitis in children aged one year and above

• The recommendation is based on a Phase 3 study showing that a significantly greater proportion of children receiving Dupixent achieved histological remission than those receiving placebo, consistent with the improvements seen in adults and adolescents.
• If approved, Dupixent would be the first and only medicine in the EU approved for the treatment of EoE in this age group.

Paris and Tarrytown, NY, September 20, 2024. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the extended marketing authorisation of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children up to one year of age. The recommendation applies to children aged 1 to 11 years who weigh at least 15 kg and whose clinical picture is inadequate, who cannot tolerate conventional drug therapy or for whom such therapy is not an option. The final decision of the European Commission is expected in the coming months. Dupixent is already approved in the EU for certain adults and adolescents aged 12 years and over with EoE.

The CHMP's positive opinion is supported by a two-part (Parts A and B) Phase 3 EoE KIDS study in children aged one to eleven years. In Part A, a significantly greater proportion of children receiving weight-based doses of Dupixent achieved histological remission of disease at Week 16 compared with placebo, with results sustained up to one year in Part B. At Week 16, caregivers of children treated with Dupixent also noted improvements in the frequency and severity of EoE signs, as well as fewer days with at least one sign of EoE compared with placebo. These data provide a bridge showing that the response to Dupixent in children with EoE is similar to that seen in the approved adult and adolescent EoE populations.

The safety results from the EoE KIDS study were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. Adverse reactions observed more frequently with Dupixent (≥10%) in both weight-based dosing regimens compared with placebo during Part A were COVID-19, nausea, injection site pain, and headache. The long-term safety profile of Dupixent evaluated in Part B was similar to that observed in Part A.

The results of the study were recently published in The New England Journal of Medicine.

The use of Dupixent in children aged one to eleven years with EoE is under development in the EU and is not yet approved.

About EoE
EoE is a chronic, progressive disease that involves type 2 inflammation, which is thought to be responsible for damage to the esophagus and impairment of its function. Diagnosis is difficult because symptoms can be confused with those of other conditions and there are delays in diagnosis. EoE can severely affect a child's eating habits, causing vomiting, abdominal pain, difficulty swallowing, decreased appetite, and failure to thrive. Ongoing treatment of EoE may be necessary to reduce the risk of complications and disease progression.

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