Panel: risk/benefit favorable for GW Epidiolex

An FDA advisory committee voted 13-0 that the benefit-risk profile of Epidiolex cannabidiol from GW Pharmaceuticals plc (NASDAQ:GWPH) was favorable to treat seizures in patients with Lennox-Gastaut syndrome and Dravet syndrome ages two years and older. The candidate’s PDUFA date is June 27.

In briefing documents released ahead of the Peripheral and Central Nervous System Drugs Advisory Committee's meeting, FDA reviewers said Phase III data provided “substantial evidence” of the product’s efficacy, and said risks of liver injury could be managed...