(Reuters) – GW Pharmaceuticals Plc’s cannabis-derived drug to treat a severe form of childhood epilepsy was unanimously backed on Thursday by an advisory panel to the U.S. Food and Drug Administration.
The 13-to-0 vote sets the stage for the approval of the first-ever cannabis-derived treatment in the United States.
The panel’s backing was widely expected, after FDA staff on Tuesday gave a favorable review citing findings from three clinical studies that showed the drug reduced frequency of seizures in patients with the disease when added to a current therapy.
The FDA does not have to act on the recommendations of its experts, but typically does.
A potential approval of the drug, Epidiolex, a final decision on which is due by June 27, would confirm the therapeutic benefits of cannabidiol (CBD) – an active ingredient found in marijuana from which the drug is derived.
Epidiolex is designed to treat Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.
“There is little evidence that CBD has meaningful abuse potential,” an FDA staffer said during the meeting.
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