GW Pharmaceuticals gains approval from European Commission for EPIDYOLEX®

EPIDYOLEX was approved in the EU after four randomized and controlled Phase 3 trials had been conducted

Bethan Rose Jenkins, Cannabis News Writer/Editorial

British drugs company GW Pharmaceuticals celebrated approval for its cannabinoid-based epilepsy medicine EPIDYOLEX® back in June 2018 in the United States. 

Now, EPIDYOLEX has also gained approval from the European Commission, thus allowing the epilepsy treatment to be prescribed to diagnosed patients of Lennox-Gastaut and Dravet syndrome throughout the European Union (EU).

GW Pharma is a pioneer in the discovery, development, and commercialization of prescribed medicines containing cannabinoids; naturally occurring active constituents contained in the cannabis plant. The cannabinoid contained in EPIDYOLEX is cannabidiol (CBD) – a non-psychotropic substance with anxiolytic, analgesic and anti-inflammatory effects.

Marketing authorization for the product has been given the go-ahead by the FDA, which makes the medicine accessible to patients aged two and above in the EU.  

“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,” said GW’s Chief Executive Officer, Justin Gover. “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.”

Clinical evaluation of EPIDYOLEX demonstrated reduction in seizure frequency

EPIDYOLEX was approved in the EU after four randomized and controlled Phase 3 trials had been conducted. Data drawn from over 740 patients who suffered from either Dravet Syndrome or LGS was featured in the clinical evaluation of GW Pharma’s medicine for epilepsy.

Both Dravet Syndrome and LGS are two rare forms of epilepsy. One study revealed how a third of patients who suffer from either disease are resistant to anticonvulsant therapy. Enduring numerous seizures per day means that patients run the risk of injuring themselves without the right treatment. 

“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 the Chairman of the Dravet Syndrome European Federation, Isabella Brambilla. “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.”

Minor adverse reactions of EPIDYOLEX were noted following controlled clinical evaluation

No other clinical evaluation of a cannabinoid-based epilepsy medication for patients with Dravet Syndrome and LGS has ever been conducted with the level of control that GW Pharma executed.

However, it should be noted that adverse reactions were noticeable in some instances, with subtle side effects of EPIDYOLEX ranging from appetite, diarrhea, fatigue, somnolence, pyrexia, and vomiting. Nonetheless, combining the medicine with alternative anti-epileptic therapies resulted in a major increase in seizures for patients with both types of epilepsy.

All 28 countries contained in the EU are included in the decision to legalize EPIDYOLEX on a doctor-prescribed basis. Those countries include Austria, Belgium, Hungary, Lithuania, Poland, Spain, and Sweden.