FDA Approves First Drug with API Derived from MarijuanaBy
The US Food and Drug Administration (FDA) has approved Epidiolex (cannabidiol [CBD]) oral solution from GW Pharmaceuticals, a London-based biopharmaceutical company, for treating seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana, according to information from the FDA. It is also the first FDA approval of a drug for treating Dravet syndrome.
CBD is a chemical component of the cannabis sativa plant, more commonly known as marijuana. However, CBD does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of marijuana.
Epidiolex will be marketed in the US by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals. Product availability is pending rescheduling, which is expected to occur within 90 days. Epidiolex is expected to be available to patients by the fall of 2018.
Outside the US, the drug is currently under review by the European Medicines Agency (EMA) for treating seizures associated with Lennox-Gastaut syndrome and Dravet Syndrome. An EMA decision on whether to recommend approval is expected in the first quarter of 2019.
Some analysts have projected near-term blockbuster status for the drug. A recent analysis by Clarivate Analytics projects sales of $1.191 billion in 2022.
Source: FDA and GW Pharmaceuticals