Epidyolex approved by the European Medicines Agency

GW Pharmaceuticals announced on 23 September the Marketing Authorization (MA) approval of its anti-epileptic drug Epidyolex (Epidiolex in the United States) by the European Medicines Agency (EMA) as an orphan drug (drugs used in rare diseases) .

Epidiolex (cannabidiol oral solution) is the first cannabinoid-based drug (in this case CBD – cannabidiol), of plant origin, to have its AIM approved by the European Medicines Agency (EMA). In July 2019, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the drug, where it recommended deferring the MA application for this indication.

According to official document of the EMA, Epidyolex is used to treat seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients aged two years and over, together with Clobazam, in addition to the treatment of tuberous sclerosis . The EMA's approval was based on data from four phase III studies, which evaluated Epidiolex in 714 patients with LGS or Dravet syndrome. When added to other anti-epileptic therapies, Epidyolex significantly reduced seizure frequency in the patient population in question.