GW Pharma gets FDA panel nod, first cannabis-based drug nearing approval

(Reuters) – An advisory panel to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of approving the first cannabis-derived medicine in the country, a childhood epilepsy treatment developed by GW Pharma.

The drug, Epidiolex, is derived from cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and an FDA decision is expected by June 27.

The syrup contains less than 0.1 percent of tetrahydrocannabinol (THC), the substance that makes people high.

The FDA panel found that the drug’s benefits outweighed the risks to treat patients aged 2 years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.

The agency does not have to act on the recommendations of its experts, but usually does.

“The overall tone of the meeting was positive, with the FDA having identified no obstacles to approval,” Cantor Fitzgerald analyst Elemer Piros said, adding that he expects the drug will be approved much before June 27.

Cowen analysts forecast sales of $1.3 billion for the drug by 2022.

The panel’s backing comes after the FDA staff on…

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