Dupixent recommended for EU approval by CHMP to treat eosinophilic esophagitis in children as young as 1 year old: Sanofi
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-22 08:00 GMT | Update On 2024-09-22 08:01 GMT
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Paris: Sanofi has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the expanded approval of Dupixent (dupilumab) in the European Union (EU) for eosinophilic esophagitis (EoE) in children down to 1 year of age. The recommendation is for children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision in the coming months. Dupixent is already approved in the EU for certain adults and adolescents aged 12 years and older with EoE.
The positive CHMP opinion is supported by a two-part (Part A and B) EoE KIDS phase 3 study in children aged one to 11 years. In Part A, a significantly greater proportion of children receiving weight-based doses of Dupixent achieved histological disease remission at week 16, compared to placebo, with results sustained for up to one year in Part B. At week 16, caregivers of children treated with Dupixent also observed improvements in the frequency and severity of EoE signs, and fewer days with at least one sign of EoE, compared to placebo. These data established a bridge showing the response to Dupixent in children with EoE is similar to that of the approved adult and adolescent EoE populations.
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