The CBD-based medicine Epidyolex, produced by GW Pharmaceuticals, has been authorised to treat seizures associated withwith Lennox‑Gastaut syndrome (LGS) or Dravet syndrome. It is approved for use from age two.
Justin Gover, GW’s CEO, says: “This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community. We believe patients and physicians deserve access to rigorously tested and evaluated cannabis-based medicines, manufactured to the highest standards and approved by medicines regulators, and we are delighted to be the first to offer this solution to the epilepsy community.”
The approval of cannabidiol oral solution is based on results from four trials, based on data from more than 714 patients with either LGS or Dravet syndrome.
These severe forms of epilepsy with high mortality rates and can cause several health complications, placing 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.
“The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex and life-long forms of epilepsy,” said Isabella Brambilla, chairman, Dravet Syndrome European Federation.
“We are very happy that patients will now have access to a much-needed, new treatment option, and one routed through a rigorous clinical trials programme and licensed by the EMA.”
When added to other anti-epileptic therapies, Epidyolex significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
The most common adverse reactions that occurred in patients treated with the medicine were somnolence, decreased appetite, diarrhoea, pyrexia, fatigue and vomiting.
The European Commission decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein.