First Marijuana-Based Medicine Is Approved for Sale in U.S.

(Bloomberg) -- The first-ever medical treatment derived from a marijuana plant will hit the U.S. market in a few months after regulators on Monday gave the epilepsy treatment the green light.

The Food and Drug Administration approved GW Pharmaceuticals Plc’s Epidiolex to treat two rare forms of childhood epilepsy, according to a statement from the agency. The liquid is made from a compound in the marijuana plant called cannabidiol, a different chemical from tetrahydrocannabinol, or THC, which gets users high.

Epilepsy patients and doctors have long had interest in marijuana’s therapeutic potential. The approval marks the first time patients will have access in the U.S. to a cannabis-derived drug that has undergone a safety and efficacy review by the FDA.

“The same principles around any prescription medication can now be applied to cannabis-based medications,” GW Pharma Chief Executive Officer Justin Gover said in an interview before the FDA’s decision. “That underlies the whole value of this. We now remove ourselves from being a special case and now meet the standard criteria for prescription medications.”

FDA Commissioner Scott Gottlieb issued a separate statement stressing the importance of proper research on medical uses of marijuana and cautioning other companies that might try to push their pot treatments.

“This is an important medical advance,” Gottlieb said of Epidiolex. “But it’s also important to note that this is not an approval of marijuana or all of its components.”

GW Pharma’s American depositary receipts fell less than 1 percent to $149.85 at 1:03 p.m. in New York. They had gained 15 percent this year through Friday’s close.

GW Pharma has to wait to sell Epidiolex until the Drug Enforcement Administration decides what restrictions to place on the drug to ensure that it reaches only the patients for whom it is intended. The DEA, which classifies marijuana as an illegal drug, is required to make that determination in 90 days, Gover said. FDA staff said at an April meeting on the drug with outside advisers that cannibidiol, known as CBD, “does not appear to have abuse potential.”

Severe Forms

Epidiolex is approved to treat Lennox-Gastaut and Dravet syndromes in patients age 2 or older. Both are considered severe forms of epilepsy that begin in childhood. They’re resistant to many existing treatments, and as many as 20 percent of children with Dravet syndrome die before reaching adulthood, according to the National Institutes of Health.

GW Pharma will make Epidiolex in the U.K., where the company is based, Gover said, and export the finished product to the U.S. As of last week, the company hadn’t determined the price but was in preliminary talks with insurance companies to make them aware Epidiolex is coming, he said.

While Epidiolex is the first approved medicine that comes from a pot plant, the FDA has allowed the use a few drugs made from synthetic cannabinoids, including Insys Therapeutics Inc.’s Syndros for loss of appetite in people with AIDS and nausea caused by chemotherapy. Insys is developing a cannabidiol oral solution for a severe type of epileptic seizure known as infantile spasms, and childhood epilepsy defined by staring spells where the child isn’t aware or responsive.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet

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