EU Medicines Committee Approves Cannabis-Based Drug Epidiolex
The Committee for Medicinal Products of the European Medicines Agency (EMA) has approved the cannabis-based drug Epidiolex, which contains cannabidiol (CBD). The product was developed and tested by the British company GW Pharmaceuticals.
Epidiolex Recommended for Epilepsy Treatment
The committee members have approved the use of Epidiolex for treating two types of epilepsy in children aged two years and older: Dravet syndrome and Lennox-Gastaut syndrome. Experts recommend taking the medication in combination with clobazam, a drug from the benzodiazepine group.
The agency issued a positive verdict because GW Pharmaceuticals was able to demonstrate the effectiveness of cannabidiol during phase three clinical trials conducted in 2015. A total of 714 volunteers suffering from Dravet and Lennox-Gastaut syndromes participated in the testing. These conditions are characterized by frequent seizures and have a devastating impact on children’s health.
Dr. Antonio Reinos, who leads the epilepsy treatment program at a Madrid hospital, shared his opinion on Epidiolex: “In my clinic, I often see patients with types of epilepsy that are difficult to treat with traditional medication. Patients and their families face severe challenges, and few are able to control the seizures. The results of scientific research and the opinion of the European Agency staff indicate that Epidiolex has great potential. This medication will improve the lives of many people.”
EU Authorities May Approve Epidiolex Use
GW Pharmaceuticals CEO Justin Gover stated that Epidiolex is the first drug in a new class of epilepsy treatments. In his view, Europe has made a historic breakthrough by beginning to consider cannabis as a medicine. The EMA leadership has promised to take the Committee’s recommendations into account and make a final decision on Epidiolex approval within the next two months.
In 2018, Epidiolex became the first and only cannabis-based medication approved by the U.S. Food and Drug Administration (FDA). It contains purified CBD extracted from plant material. The product is safe for health and meets the quality standards in effect in the United States.