The FDA approved the first drug with an active ingredient derived from marijuana to treat rare, severe forms of epilepsy.
Cannabidiol (Epidiolex), an oral solution to treat seizures in Lennox-Gastaut Syndrome (LGS) and Dravet syndrome, was approved for patients two years of age and older.
"The FDA approval for cannabidiol is a landmark in American medicine," said Orrin Devinsky, MD, of New York University Langone Health, who helped lead the product's major clinical trials.
"This is the first time the government has approved a compound derived from the cannabis plant to treat any disorder -- in this case, severe epilepsy due to Dravet and Lennox Gastaut syndromes. This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards."
Cannabidiol (CBD) is the first FDA-approved drug derived from marijuana and the first FDA-approved drug to treat patients with Dravet syndrome. It is a chemical component of the Cannabis sativa plant and does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC). Epidiolex is a pharmaceutical-grade formulation; the approval was granted to GW Research Ltd.
LGS and Dravet syndrome are rare, severe, refractory epilepsy syndromes that emerge early in childhood. Both are linked to higher rates of mortality, primarily due to status epilepticus and sudden unexpected death in epilepsy patients (SUDEP).
An FDA advisory committee in April had recommended unanimously that Epidiolex be approved.