GW Pharmaceuticals paved a way to launch Epidyolex in Europe, 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 company got approval from European Commission (EC), which is a significant milestone, offering patients and their families the first in a new class of epilepsy medicines.
“(This is) first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” said Justin Gover, GW’s Chief Executive Officer.
The approval of cannabidiol oral solution is based on results from four randomised, controlled Phase 3 trials, GW said. 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, the company said. 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.
Professor Elinor Ben-Menachem, University of Goteborg, Sahlgren Academy and Hospital in Sweden, said that LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy, with few patients achieving adequate seizure control. Profesor Ben-Menachem said that the EMA approval of Epidyolex will bring hope to patients and families, with the potential to better control seizures and improve quality of life.