Drug Made From Cannabis Plant Gets Backing From FDA Staff

An experimental drug from GW Pharma has received support from the federal government.

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April 18, 2018

An experimental medication that could become the first drug derived from a marijuana plant approved in the U.S. received a boost from Food and Drug Administration staff.

The treatment’s maker, U.K. company GW Pharmaceuticals Plc, provided “substantial evidence” of the drug’s effectiveness, FDA staff said in a report released Tuesday. The medication would treat seizures associated with two rare forms of epilepsy that typically affect children, according to the report. Although the medication appears to have an increased risk of liver injury, it could be managed, the report said.

“The risk-benefit profile established by the data in the application appears to support approval of cannabidiol,” FDA staff wrote.

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