An FDA First
Does Epidiolex represent a watershed for cannabis-derived medicines in the US?
In June, Epidiolex became the first ever drug comprised of an active ingredient derived from cannabis to receive FDA approval. The drug has been found to reduce seizures in two severe childhood epilepsies – Lennox-Gastaut syndrome and Dravet syndrome. The strawberry-flavored liquid has already been used to treat 1,500 children with the conditions worldwide under a compassionate use program. With no current treatment options for Dravet syndrome, the application was fast tracked and Epidiolex was designated an orphan drug, which grants the developer tax credits and seven years of marketing exclusivity.
UK-based GW Pharmaceuticals produce the drug by extracting CBD from cannabis plants grown legally in the East of England. FDA Commissioner Scott Gottlieb said in a statement “Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery.”
However, Gottlieb was quick to note that the agency will still take action against “illegal marketing of CBD-containing products with serious, unproven medical claims.”
