FDA approves first marijuana-derived drug, for epilepsy

The Food and Drug Administration approved for the first time Monday a drug derived from marijuana -- to treat epilepsy -- as well as its first medication of any kind for Dravet syndrome.

The FDA green-lighted Epidiolex for the treatment of seizures associated with two rare and severe forms of epilepsy -- Lennox-Gastaut syndrome and Dravet syndrome.
The drug, manufactured by GW Pharmaceuticals, is made from the cannabidiol (CBD) chemical component of the Cannabis sativa plant.

GW CEO Justin Gover called the approval a "historic milestone."

The FDA said, though, CBD does not cause "intoxication or euphoria" that comes from marijuana.

Epidiolex will go to patients with both severe forms of epilepsy.

Monday marked the FDA's first approval of a drug containing a substance derived from marijuana. It's also the agency's first approved drug targeting 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," FDA Commissioner Scott Gottlieb said.

Dravet syndrome is a rare genetic condition that starts with fever-related seizures in a newborn's first year, before other seizures arise later.

Doctors say Lennox-Gastaut syndrome begins with multiple types of seizures, usually between ages 3 and 5. Learning disabilities are associated with both conditions.

"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life," said Billy Dunn, M.D., director of the FDA's Division of Neurology Products. "This first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement."

Epidiolex's effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either syndrome. Epidiolex, taken with other medications, was shown to be effective in reducing the seizures frequency in comparison to a placebo.
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