Sanofi (SNY) said Wednesday that the European Medicines Agency has approved its drug Dupixent to treat eosinophilic esophagitis in children from one year of age.
Approval for the drug, also called dupilumab and jointly developed by Regeneron Pharmaceuticals (REGN), covers children ages one to 11 years weighing at least 15 kilograms and unable to use conventional medicinal therapies, the company said.
The approval makes dupilumab the first and only medicine to treat children with such conditions, the company said.
It followed a phase 3 study in which 68% of patients experienced disease remission compared to 3% in a control group.
Eosinophilic esophagitis is a chronic, progressive disease that potentially damages the esophagus and impairs its function.
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