Medicinal cannabis product Epidyolex approved in EU for childhood epilepsy
pharmafile | September 24, 2019 | News story | Manufacturing and Production, Research and Development |
GW Pharmaceuticals, a world leader in the development of cannabinoid prescription drugs has announced it has received approval from the European Commission for Epidyolex, for use as adjunctive therapy in childhood epilepsy.
Justin Gover, Chief Executive at GW Pharmaceuticals, 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 we are delighted to be the first to offer this solution to the epilepsy community.”
The approval comes on the back of data from trials using more than 700 patients with either Lennox-Gastaut syndrome (LGS) or Dravet syndrome which places a significant burden on families and caregivers.
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.
GW’s oral solution has already been approved by the US FDA in June 2018 under the trade name Epidiolex in the same indication.
The European Comission decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein.
Nik Kiran
