First U.S. cannabis-derived drug has been approved by the FDA
The first cannabis-derived drug has been approved by the Food and Drug Administration. The drug, epidiolex, is intended for seizures associated with two rare types of childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. Epidiolex contains cannabidiol (CBD), as opposed to the psychoactive component of cannabis, THC, but the product remains a controlled substance and can’t be sold until the Drug Enforcement Administration makes a final scheduling decision, according to the approval letter. GW Pharmaceuticals shares declined about 1% in Monday midday trade. Approval of the drug has been expected since a favorable FDA advisory committee recommendation in April. As part of the approval, the FDA also granted the company a rare pediatric disease priority review voucher, which allows for priority review of a drug; the vouchers have also been sold for hefty sums. “This is an important medical advance,” FDA Commissioner Scott Gottlieb said in a Monday announcement. “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use.” But he went on to warn about “the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims,” including oil drops, capsules, syrups, teas and lotions illegally marketed as treatments or cures for diseases like cancer. GW Pharma shares have surged 29% over the last three months, compared with a 4.8% rise in the S&P 500 and a nearly 3% rise in the Dow Jones Industrial Average .
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