Positive CHMP opinion for Epidyolex for the treatment of seizures associated with Lennox?Gastaut syndrome or Dravet syndrome

GW Pharmaceuticals plc announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation of Epidyolex (cannabidiol oral solution) for use as adjunctive therapy of seizures associated with Lennox?Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients 2 years of age and older. The European Commission (EC) is expected to make a final decision on the marketing authorisation application (MAA) in approximately two months

Comment: Epidiolex received FDA approval in June 2018 and is indicated for patients with two forms of epilepsy called Lennox-Gastaut syndrome and Dravet syndrome. Net US sales of Epidiolex exceeded expectations and totaled $33.5 million in the first quarter, more than double what analysts had predicted.