29 December 2017 - GW Pharmaceuticals today announced it has submitted its marketing authorisation application to the EMA for Epidiolex (cannabidiol) as adjunctive treatment for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy. 

GW has received orphan designations from the EMA for Epidiolex for the treatment of Lennox-Gastaut syndrome, Dravet syndrome, and recently, West syndrome and tuberous sclerosis complex.

The application for Epidiolex is supported by data from three Phase 3 safety and efficacy studies, each of which met their primary endpoint. Epidiolex was generally well tolerated in these trials. The application includes safety data on approximately 1,500 patients, with approximately 400 patients on continuous therapy for more than one year. Approximately 26% of the Epidiolex patients from the Phase 3 pivotal program came from European sites.

Read GW Pharmaceuticals press release