FDA Grants U.K. Firm Incentives to Develop Cannabis-Based Drug

U.S. regulators granted GW Pharmaceuticals’ cannabis-based epilepsy drug “orphan” status, enabling the company to receive tax credits and other incentives so it can test the drug on patients with a rare form of the disorder.

The U.S. Food and Drug Administration’s decision gives British-based GW the green light to test its Epidiolex medicine for treating Tuberous Sclerosis Complex (TSC), a rare genetic disorder for which the most common symptom is epilepsy.

Approximately 50,000 people in the United States and nearly 1 million people worldwide are estimated to have TSC, and 80% to 90% of them have epilepsy.

FDA orphan drug designation gives companies special incentives to develop and test drugs on rare diseases, defined as those affecting fewer than 200,000 people in the United States.

GW announced on April 11 it had started a clinical trial to determine whether Epidiolex can treat seizures linked to TSC.

Last month, the drug company announced that in a clinical trial Epidiolex had successfully treated another rare form of severe epilepsy, Dravet syndrome. The news sent GW’s stock soaring. Epidiolex could be on the market next year for the treatment of Dravet syndrome, and is in trial for the treatment of another rare form of epilepsy, Lennox-Gastaut syndrome.