The U.S. Food and Drug Administration (FDA) has granted GW Pharmaceuticals Plc's experimental cannabis-derived epilepsy drug "orphan" status for a third group of patients affected by a rare form of the disease.
GW said on Thursday that its drug, Epidiolex, had been granted the status for the treatment of tuberous sclerosis complex (TSC), a rare genetic disorder that causes epilepsy in about 80 percent to 90 percent of the patients afflicted with it.
TSC is the third orphan indication that GW is targeting within its Epidiolex clinical development program.
Orphan status is granted to drugs aimed at treating rare diseases, giving the developer incentives such as a seven-year marketing exclusivity in the United States.
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Reuters ~
