GW Pharmaceuticals’ marijuana-based treatment Epidyolex 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.
The CHMP’s positive opinion is based on results from four randomised, controlled Phase III trials, the company said.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months. GW expects a final decision in about two months.
Last year, the drug became the first cannabis-based medicine to be approved in the United States under the brand name Epidiolex 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.
Analysts at Cantor Fitzgerald said they don’t anticipate the need for the treatment to be co-administered with clobazam to be an issue. “Given the high unmet medical need for these patients in EU, we expect the drug will be prescribed broadly.”
They predict the treatment will launch in 2020 with initial sales of about $80 million and peak Europe sales of about $500 million.
Epidiolex is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1% of tetrahydrocannabinol (THC), the psychoactive component that makes people high.
GW Pharmaceuticals said in May the treatment 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. (Reporting by Noor Zainab Hussain in Bengaluru; Editing by Bernard Orr and Shailesh Kuber)