A European Medicines Agency (EMA) committee has approved in principle what could be the first plant-derived cannabis-based medicine to be approved in Europe for the treatment of any form of epilepsy.
The European Commission will now make a final decision on the marketing authorisation application for Epidyolex (GW Pharmaceuticals), expected by September 2019.
The EMA’s Committee for Medicinal Products for Human Use has granted a positive opinion for Epidyolex (cannabidiol [CBD] oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS).
The CBD oral solution has been recommended as an adjunctive therapy for use in conjunction with clobazam for patients aged two years and older.
“This is a significant milestone for patients with LGS and DS, as there remains a severe unmet medical need for these rare, lifelong forms of epilepsy,” said Martin Brodie, president of the International Bureau for Epilepsy.
“Today’s positive opinion brings hope, to both patients and their families, of a treatment option which has the potential to better control seizures and notably improve quality of life.”
The positive opinion was based on the results of four randomised controlled phase III trials comprising more than 714 patients with either LGS or DS.
Currently, the only cannabis-based medical product licensed by the Medicines and Healthcare product Regulatory Agency is nabiximols (Sativex; GW Pharmaceuticals) for the treatment of multiple sclerosis.
The US Food and Drug Administration approved GW’s cannabidiol oral solution in June 2018 under the trade name Epidiolex for the treatment of seizures associated with LGS or DS in patients two years of age or older.