European Commission approves Epidyolix for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.- GW Pharma

GW Pharmaceuticals plc , world leader in discovering, developing and commercialising cannabinoid prescription medicines, announces that the European Commission (EC) has approved the marketing authorisation for Epidyolix 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 approval paves the way for the launch of the medicine across Europe.

The approval of cannabidiol oral solution is based on results from four randomised, controlled Phase III trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers. Many patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at ongoing risk of falls and injury. Despite current anti-epileptic drug treatment, both of these severe forms of epilepsy remain highly treatment-resistant.

Comment: Cannabidiol oral solution was approved by the FDA in June 2018 for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome.