GW Pharmaceuticals’ marijuana-based treatment Epidiolex has won a positive recommendation for marketing approval from a European Medicines Agency (EMA) panel on Friday for use as an additional treatment for two types of seizures.
EMA’s human medicines committee (CHMP) cleared the cannabidiol oral solution for use with clobazam to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients aged two and older.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months. The CHMP’s positive opinion is based on results from four randomised, controlled Phase III trials, the company said.
Last year, the drug became the first cannabis-based medicine to be approved in the United States after regulators permitted the treatment for two other forms of childhood epilepsy.
The U.S. Drug Enforcement Administration has labelled the drug as having a low abuse potential.
Epidiolex is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.
GW Pharmaceuticals said in May, Epidiolex was successful in treating seizures in patients with a rare form of childhood epilepsy called tuberous sclerosis complex during a late-stage trial.
GW Pharmaceuticals grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD.