BioCentury
ARTICLE | Clinical News

FDA grants Priority Review to GW's Epidiolex for seizures

January 3, 2018 11:12 PM UTC

GW Pharmaceuticals plc (NASDAQ:GWPH) said FDA accepted and granted Priority Review to an NDA for Epidiolex cannabidiol as an adjunctive treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Its PDUFA date is June 27.

GW expects an FDA advisory committee to discuss the NDA. The company has also submitted an MAA to EMA for Epidiolex in the indication. The candidate is an oral liquid formulation of cannabidiol, a phytocannabinoid found in Cannabis sativa...

BCIQ Company Profiles

GW Pharmaceuticals plc

BCIQ Target Profiles

Cannabinoid receptors