Following this week’s announcement by GW Pharmaceuticals plc (NASDAQ:GWPH) that the drug Epidiolex was accepted for filing with Priority Review by the U.S. Food and Drug Administration, comes news that the company submitted a Marketing Authorisation Application to the European Medicines Agency. In a statement released Friday GW noted that they have already received the EMA’s Orphan Designations for the drug for the treatment of LGS, Dravet syndrome, West syndrome, and Tuberous Sclerosis Complex. Data from three Phase 3 safety and efficacy studies preceded the application, each of which met their primary endpoint.
GW’s lead cannabinoid product candidate, Epidiolex is a pharmaceutical formulation of purified cannabidiol. The company hopes to receive approval to market the drug for the treatment of several rare childhood-onset epilepsy disorders. Earlier this month, GW Pharma announced the end of their licensing agreement with Otsuka Pharmaceutical Co., Ltd. over another drug Sativex.