FDA greenlights GW's Epidiolex, the first U.S. drug made from marijuana

The FDA just approved Epidiolex, the GW Pharma seizure drug derived from cannabis, giving children with two rare and serious forms of epilepsy a new treatment—and companies looking to develop marijuana-based drugs a model for their own path to market. The agency approved Epidiolex, or purified cannabidiol, to treat Lennox-Gastaut syndrome and Dravet syndrome in patients 2 and older. The conditions typically begin in childhood, with frequent or prolonged seizures, and patients have a high risk of death from seizure-related causes and infections. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome. GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA. Though CBD doesn't induce the high associated with marijuana use—THC does that—it's now classified as Schedule I, a category that covers drugs with no therapeutic value and high probability of abuse. The company said it expects the DEA to act "within 90 days" and plans to roll out the drug this fall.