Epidiolex NDA accepted for priority review

The US Food and Drug Administration has accepted for filing with Priority Review the recently submitted New Drug Application (NDA) for Epidiolex (cannabidiol or CBD), an investigational treatment for seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy.

The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018, the drug’s developer, UK-based cannabinoid product specialist GW Pharmaceuticals (Nasdaq: GWPH), announced today.

GW has previously received Rare Pediatric Disease and Orphan Drug designations from the FDA for Epidiolex in the treatment of both LGS and Dravet syndrome