This is a make-or-break spring for GW Pharmaceuticals and its billion-dollar investment in a cannabidiol-based drug.
The London-based firm aims to develop the first FDA-approved medicine from plant-derived cannabis compounds. The U.S. Food and Drug Administration could decide as early as June 27 whether Epidiolex, a CBD oral solution, could be prescribed to patients with rare epilepsy conditions.
And as GW prepares for a Thursday hearing of a FDA advisory committee, it appears the odds are in the company’s favor.
Epidiolex this week received a positive review from FDA clinicians. The agency isn’t obligated to follow recommendations from the clinical briefing or even the advisory committee, but positive reviews put Epiodiolex on good footing.
The Cannabist spoke with GW Pharmaceuticals CEO Justin Gover In advance of Thursday’s hearing for an update on Epidiolex’s progress, his perspective on the medicine’s potential, his views on the future for cannabinoid pharmaceuticals, and how an FDA-approved CBD drug could affect the booming business of cannabis extracts.
“We consider ourselves to be world leaders,” he said. “Our job is to stay in that position as long as we can.”
The fact that Epidolex is derived from the cannabis plant, adds a “layer of interest” that GW is prepared to address, Gover said.
Epidiolex would be a first-of-its-kind drug, so the scheduled committee hearing — in this case the Peripheral and Central Nervous System Drugs Advisory Committee hearing — was not unexpected, he said.
“(Our) focus will be on the patient population and whether this meets the standard for a new treatment,” he said.
GW’s intends to demonstrate Epidiolex’s safety and efficacy was adequately characterized, explain the level of unmet need, detail the rigor of the pre-clinical and clinical studies and discuss the quality of the evidence, Gover said. Ultimately, GW