GW Pharmaceuticals Completes Rolling New Drug Application Submission to FDA for Epidiolex

Nov 09, 2017
By Pharmaceutical Executive Editors
GW Pharmaceuticals (London, UK, and Carlsbad, CA), along with US subsidiary Greenwich Biosciences, today announced that it has completed the rolling submission of a New Drug Application (NDA) to 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 Pediatric Disease and Orphan Drug Designations from FDA for Epidiolex—which features in Pharm Exec's latest Pipeline Report—in the treatment of both LGS and Dravet syndrome. Additionally, GW has received Fast Track Designation from FDA for the drug for the treatment of Dravet syndrome.
 
The NDA 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 NDA 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. 
 
GW reports that it plans to file a Marketing Authorization Application (MAA) in Europe for Epidiolex in the near future.
 
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