08:26 AM EDT, 09/20/2024 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) and Sanofi ( SNY ) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the expanded approval of its eosinophilic esophagitis drug Dupixent to treat children 1 to 11 years old.
Dupixent, a human monoclonal antibody developed using Regeneron's VelocImmune technology, is already approved in the EU for use in adolescents at least 12 years old and adults with eosinophilic esophagitis.
The companies said the committee's positive opinion is based on the results of a phase 3 study showing that children's response to Dupixent is similar to that of the adolescents and adults.