The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of Epidyolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS).
If approved, it will be the first plant-derived cannabis-based medicine to be approved in Europe for the treatment of any form of epilepsy.
The CHMP’s positive opinion is based on results from four randomised controlled, phase 3 trials including more than 700 patients with LGS or DS, according to the marketing authorisation applicant, GW Pharma (International) BV.
The EMA committee noted the benefit of the medicine is its ability to help manage seizures associated with LGS and DS. The most common side effects are somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting.
Epidyolex will be available as 100 mg/mL oral solution and, if approved, will be indicated for use as adjunctive therapy of seizures associated with LGS or DS in conjunction with clobazam, for patients aged two years and older. It is proposed that Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy.
A final decision on the application will be made by the European Commission in the coming weeks.