Epidiolex, and oral solution of pure plant-derived cannabidiol, or CBD, is GW’s lead candidate in development for severe, orphan, treatment-resistant epilepsy syndromes such as Dravet syndrome and Lennox-Gastaut syndrome (LGS).
Last month the London, UK-headquartered firm submitted its New Drug Application (NDA) for Epidiolex to the US Food and Drug Administration (FDA) to review, and speaking on a Q4 financial call yesterday said it is hopeful the drug will be approved next year.
“We expect to hear from the FDA at day 60, around the end of December, regarding whether the agency will accept the filing. At this time, we would expect to receive confirmation of an expedited review of the NDA. If so, this would lead to an expected PDUFA date in mid-2018,” said CEO Justin Gover.
He confirmed the firm’s manufacturing capabilities were prepared for a pre-approval FDA inspection, having operated to commercial GMP standard for over a decade.
“We’re inspection ready,”