U.K.’s GW Pharmaceuticals is on a bee-line path to an historic, first-ever Food and Drug Administration (FDA) approval for a marijuana-based drug—Epidiolex, which is derived from the cannabis product cannabidiol (CBD) and has shown promise in treating devastating childhood epilepsy and seizure disorders. CBD is different from the euphoric, “high” producing weed component THC.
An FDA panel on Thursday enthusiastically endorsed Epidiolex during an advisory committee meeting. In a unanimous 13-0 vote, the outside experts said GW Pharma’s experimental cannabis therapy’s benefits outweighed its risks in treating rare forms of epilepsy like Lenox-Gastaut Syndrome (LGS) and Dravet syndrome (DS), lining up a near-certain FDA approval between now and the end of June. The FDA isn’t bound to follow its advisers’ recommendations—but it almost always does, especially when the recommendation is so lopsided.
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“This is clearly a breakthrough drug for an awful disease,” said one of the panelists, Dr. John Mendelson, during the advisory committee meeting, which was also attended by patients and patient advocates urging its approval. Another panelist added that the decision to recommend Epidiolex was a “no-brainer.”
$GWPH slam dunk arrives as expected in 13 yes, 0 no vote re CBD Epidiolex in adcom on risk-benefit profile in LGS and DS. "Really a no-brainer for me," one panelist says
— BioWorld (@BioWorld) April 19, 2018
Clinical trials have shown that, with some side effects such as liver problems in certain patients, GW Pharmaceuticals’ drug significantly reduced the number of seizures experienced by children with these epilepsy disorders.
The deadline for FDA approval of the drug is toward the end of June. But it’s likely to come well before that as regulators informed the advisory panel that it would be putting Epidiolex on an accelerated review track.
GW Pharmaceuticals CEO Justin Gover has personally stated that an FDA green light “will mark a sea change in the acceptability of cannabinoids as therapy.” For instance, an approval might even mean that the Drug Enforcement Agency (DEA) would have to reschedule the specific marijuana component in the drug, CBD, because it will have proven to have a tangible medical benefit.
