Rolling submission initiated

GW Pharmaceuticals recently announced that a rolling NDA filing for Epidiolex in both Dravet syndrome and Lennox-Gastaut syndrome (LGS) is underway. The pre-clinical module has already been submitted, the clinical module is in process and the company expects to finish the chemistry, manufacturing and controls (CMC) section in October. GW anticipates the FDA will grant priority review status, which would enable a June 2018 PDUFA date. In Europe, pre-submission meetings were held with the EMA and the agency agreed that the company can file for approval for Dravet and LGS in a single application. An EMA filing is expected in Q417.