FDA Advisory Committee Recommends Approval for Cannabis Derived Treatment for Epilepsy

An FDA advisory committee voted unanimously to recommend approval of a drug for Lennox-Gastaut syndrome and Dravet syndrome that, if approved, would be the first FDA-approved cannabis-derived product, GW Pharma’s NDA for a cannabidiol oral solution.

Peripheral and Central Nervous System Drugs Advisory Committee members cited the number of studies performed for GW Pharma’s cannabidiol oral solution and the minimal risk of adverse events, which members said was “very manageable” with proper labeling and education.

The candidate’s PDUFA goal date is June 27, but an FDA representative noted the agency is working to expedite the review.