In a widely expected move, the United States Food and Drug Administration today announced their approval of Epidiolex, a drug derived from the extract of cannabis plants, for treatment of certain diseases which cause severe seizures. They will only allow the drug for use on patients over two years old. The newly approved drug contains Cannabidiol, or CBD, which is derived from both marijuana and industrial hemp.
The FDA said in a statement:
“The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe 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. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome …”
“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,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. 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 that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.”
The FDA granted the drug Priority Review designation for this application. Also, Fast-Track designation was previously granted for Dravet syndrome and Orphan Drug designation was granted for both syndrome indications.
According to the FDA, Fast Track is a process designed to facilitate the development, and expedite the review of drugs in order to treat serious conditions and fill an unmet medical need. It helps to get important new drugs to patients faster than traditional approval methods. The Orphan Drug designation is made possible due to the Orphan Drug Act which allows for granting special status to a drug or biological product (“drug”) to treat a rare disease or condition.