GW Pharma's cannabidiol Fast Track'd for NHIE
Cannabis extract treatment for severe childhood epilepsy to be fast-tracked in US
GW Pharmaceuticals' cannabis-extract treatment for severe childhood epilepsy is to be fast-tracked through the US drug approval system.
The Aim-listed company is currently testing its treatment, known as Epidiolex, on children with a rare but debilitating form of childhood epilepsy, known as Dravet Syndrome. Children with this condition do not respond to any existing epilepsy drugs.
US regulator the Food and Drug Administration (FDA) grants fast-track status to drugs thought to meet a previously unmet medical need. Drugs with this designation are given greater access to the regulator to help speed up the process of clinical testing, review and potential approval.
Epidiolex is already being used by seven paediatric epilepsy specialists across the US to treat patients under the FDA's "expanded access" programme after being granted orphan drug status late last year. In the US, an orphan drug...
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