In a recent announcement made Friday, July 26, CBD therapeutics provider, GW Pharmaceuticals revealed that it got an approval from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) in regard to its product, the EPIDYOLEX.
Such recognition was a result of the CBD oral solution, which can now be used as a therapy for seizures associated with LennoxGastaut (LG) and Dravet syndromes. It has been deemed appropriate for patients 2 years of age and older.
The CEO of GW Pharmaceuticals, Justin Gover has since expressed immense joy in what has been achieved, as he trusts that this would make a positive difference in patients and families trying to find solutions for childhood-induced seizures.
He elaboratively shared:
“We are excited by the potential to bring patients and physicians a rigorously tested and evaluated cannabis-based medicine with documented safety and efficacy profile manufactured to the highest standards and approved by a medicines regulator.”
The Director of the Epilepsy Programme, Dr. Antonio Gil-Nagel Rein is as excited as the CEO, especially considering the fact that he too watches the sufferings of said patients; not to mention how frustrating it can be with every failed treatment.
He further noted that:
“Based on numerous clinical trials and the scrutiny of the European medicines regulator, this medicine has the potential to make a real difference to the lives of many patients.”
In addition to the approval granted by the European medicines regulator, GW Pharmaceuticals’ EPIDYOLEX has also been approved by the U.S. Food and Drug Administration (FDA) back in 2018.
With this being said, the European Commission (EC) has 2-months to make the final call in regard to the marketing authorisation application (MAA).