First FDA approval for cannabidiol-based drug moves closer

A predicted blockbuster has moved closer to market with the news that a US Food and Drug Administration (FDA) advisory committee has recommended GW Pharmaceuticals’ (Nasdaq: GWPH) Epidiolex (plant-derived cannabidiol) for approval as an adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

Of wider interest is the fact that, if approved, Epidiolex would be the first pharmaceutical formulation of purified, plant-based cannabidiol oral solution, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.

LGS and Dravet syndrome, which develop in childhood, are forms of epilepsy with high morbidity and mortality rates. If the agency agrees with the unanimous recommendation of its committee, Epidiolex would be the first-ever FDA-approved medicine for Dravet syndrome patients.