GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) has submitted its Marketing Authorization Application to the European Medicines Agency for Epidiolex® as adjunctive treatment for seizures related with Dravet syndrome and Lennox-Gastaut syndrome, two extremely treatment-resistant types of childhood-onset epilepsy.
GW Pharmaceuticals has obtained Orphan Designations from the European Medicines Agency for Epidiolex for the cure of Dravet syndrome, LGS, and lately, West syndrome & Tuberous Sclerosis Complex. In October 2017, the company completed the filing of its rolling Epidiolex NDA to the United States FDA, also for seizures linked with Dravet syndrome and LGS. This NDA has been approved by the FDA for Priority Review.
Justin Gover, the CEO of GW Pharmaceuticals, expressed that this Marketing Authorization Application filing marks another key milestone for the Epidiolex plan and is a vital next step toward offering this prospective new treatment option internationally. The company is dedicated to making Epidiolex available to people in Europe that fight with the burden of living with Dravet syndrome and LGS, both extremely difficult to cure and devastating conditions. They continue to establish a commercial infrastructure in Europe in expectation of future approval and release.
The MAA filing for Epidiolex is supported by report from three Phase III efficacy and safety trials, each of which fulfilled their primary objective. Epidiolex was usually well tolerated in these studies. The MAA comprises safety data on around 1,500 patients, with around 400 people on continuous therapy for over one year. Around 26% of the people suffering from Epidiolex from the Phase III pivotal plan came from European sites. Beyond pivotal efficacy and safety data, the MAA comprises a comprehensive clinical pharmacology, toxicology and pre-clinical package.
In unrelated news, the GW Pharmaceuticals posted that the U.S. FDA has accepted its filing for Priority Review of its New Drug Application for Epidiolex®. The PDUFA goal date for FDA completion is June 27, 2018.