Epidiolex is now the first FDA-approved drug made up of a purified drug substance extracted from marijuana.
The US regulator said that Epidiolex is also the first approved drug for the treatment of patients with Dravet syndrome.
In three phase 3 trials, the marijuana-based drug was shown to significantly lessen the frequency of seizures in patients with LGS and Dravet syndrome when added to other antiepileptic therapies.
GW CEO Justin Gover said: “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine.
“These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
According to the FDA, cannabidiol is a chemical component of the Cannabis sativa plant, which is better known as marijuana. The regulator said that cannabidiol does not lead to intoxication or euphoria caused by tetrahydrocannabinol (THC), which is the main psychoactive component of marijuana.
FDA Commissioner Scott Gottlieb said: “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.
“And, the FDA is committed to this kind of careful scientific research and drug development.”
Gottlieb added that controlled clinical studies evaluating a drug’s safety and efficacy in combination with a careful review through the FDA’s drug approval process, is the most suitable way to introduce marijuana-based treatments to patients.
GW expects to make Epidiolex available to appropriate patients by fall 2018.
Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.