British biopharma GW Pharmaceuticals has had its cannabis-derived Epidiolex oral solution for treating two types of epileptic seizures approved in the US.
Epidiolex is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).
“Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” said Justin Gover, GW’s CEO.
“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine.
“These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
LGS and Dravet syndrome, which develop in childhood, are rare, severe forms of epilepsy that are notoriously treatment-resistant.
Most patients require multiple seizure medications and the majority are resistant to currently approved AEDs. The day-to-day impact of these conditions is significant with high rates of early mortality.
Epidiolex will be marketed in the US by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals plc.
Outside the US, this medicine is currently under review by the European Medicines Agency for the treatment of seizures associated with LGS and Dravet Syndrome.
An EMA decision on whether to recommend approval is expected in the first quarter of 2019.