On Thursday GW Pharmaceuticals plc (NASDAQ:GWPH) announced that the recently submitted New Drug Application for Epidiolex was accepted for filing with Priority Review by the U.S. Food and Drug Administration. The drug, a CBD-based treatment, is designed for patients suffering from seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two conditions that stem from childhood epilepsy. FDA review of the Epidiolex NDA, as per the PDUFA (Prescription Drug User Fee Act), is expected to be completed by June 27, 2018.
The decision by the FDA bodes well for GW and Epidiolex, as only drugs that show real promise and that fill a void where no other treatment exists receive Priority Review Status. According to a statement put out by GW Pharma, Priority Review will speed up the review time for Epidiolex as compared to the typical standard review given to most drugs.
“We are pleased with the FDA’s acceptance of