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GW Pharmaceuticals submits EMA application for epilepsy disorder drug

GW Pharmaceuticals plc submitted its marketing authorization application to the European Medicines Agency for Epidiolex as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.

Dravet syndrome is a severe infantile-onset epileptic syndrome resulting in moderate to severe intellectual and developmental disabilities, and Lennox-Gastaut syndrome is characterized by multiple types of seizures and intellectual disability.

GW Pharmaceuticals in October completed the submission of its rolling application to the U.S. Food and Drug Administration for the same indication.

The application for Epidiolex is supported by data from three phase 3 studies, each of which met their primary endpoint.