Cannabis-based child epilepsy treatment approved across Europe
Cambridge business GW Pharmaceuticals has received EC approval for its cannabis-based treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.
The UK and US company’s oral solution, EPIDYOLEX®, is the first plant-derived cannabis-based medicine to be approved by the European Medicines Agency.
The approval grants use in all 28 countries of the European Union, alongside Norway, Iceland and Liechtensteiin, as an adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome for patients aged two or older.
Justin Gover CEO of the Nasdaq-quoted company, said: “The approval of EPIDYOLEX® marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy.
“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 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 randomised, controlled Phase 3 trials.
When added to other anti-epileptic therapies, EPIDYOLEX® significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome.
GW’s cannabidiol oral solution was approved by the US Food and Drug Administration in June 2018.