EMA Committee Recommends Marketing Approval for Daybu to Treat Neurobehavioral Symptoms of Rett Syndrome

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If approved by the European Commission, Daybu would be the first therapy for this indication in the European Union.