Cannabis extract treatment for severe childhood epilepsy to be fast-tracked in US
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 is one that treats a condition that affects fewer than 200,000 people.
There are thought to be around 5,400 patients with Dravet Syndrome in the US and 6,710 in Europe.
The active ingredient in Epidiolex is a purified liquid extract from the cannabis plant, known as Cannabidiol (CBD), which does not cause highs. GW Pharmaceuticals grows its own medical-grade cannabis at a secret location in the South of England.
Justin Gover, chief executive, said the fast-track status would provide "significant additional support" for advancing Epidiolex through clinical testing.
He added that GW planned to start a larger clinical trial on children with Dravet Syndrome in the second half of this year.