Posted by Michael Wonder on 01 Nov 2017
GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
30 October 2017 - GW Pharmaceuticals today announced it has completed the rolling submission of a new drug application to the U.S. FDA for Epidiolex (cannabidiol) as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy.
GW has received rare paediatric disease and orphan drug designations from the FDA for Epidiolex in the treatment of both LGS and Dravet syndrome. Additionally, GW has received fast track designation from the FDA for Epidiolex for the treatment of Dravet syndrome.
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. Beyond pivotal safety and efficacy data, the NDA includes a comprehensive clinical pharmacology, pre-clinical and toxicology package. The CMC section of the NDA incorporates the Company's recently expanded UK manufacturing facilities.
The Company plans to file a marketing authorisation application in Europe for Epidiolex in the near future.
