Sanofi (SNYNF) Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the expanded approval of Dupixent for eosinophilic esophagitis (EoE), an allergic inflammatory condition of the esophagus, in children 1 to 11 years of age.
A final decision from the European Commission is expected in the coming months.
Dupixent is already approved in the EU to treat EoE in certain adults and adolescents aged 12 years and older.
The positive CHMP opinion is supported by results from a Phase 3 study in children with EoE.
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