Epidyolex, a CBD drug made to treat two rare forms of childhood-onset epilepsy, has been approved for distribution across the EU. This drug is made by GW Pharmaceuticals.
This is the first drug whose ingredients are extracted from cannabis to be approved in the EU region. Its counterpart, Epidiolex, made history in the U.S. when the Food and Drug Administration approved it last year to treat two rare forms of childhood epilepsy (Dravet and Lennox Gastaut symdromes).
Speaking about the decision of the EU, DW Pharmaceuticals Chief Executive Justin Gover said that the company was excited to bring to parents and their children a new line of treatment for epilepsy.
The approval came after a total of four Phase 3 clinical trials were done on a total of 714 patients. The trials demonstrated that when Epidyolex was used together with other conventional treatments, there was a marked reduction in the frequency of seizures among patients.
Some of the side effects that were documented during the clinical trials in Europe included drowsiness, a reduction in appetite, fatigue, fever, vomiting and diarrhea.
The approval of this drug in Europe comes earlier than the pharmaceutical company had expected, and the company revealed that it was planning to expand the reach of Epidiolex within the U.S.
In the second quarter of this year, Epidiolex sales brought $72 million in total revenues and yet the company had expected to earn only $47 million. By the end of August, a total of 12,000 patients in the U.S. had received this drug from the time it was launched after being approved by regulators there.
The biotech company now plans to launch Epidyolex in the UK, France and Germany this year, then the drug will be launched in Italy and Spain sometime next year.
The approval of such drugs derived from cannabis, and the acceptance of those drugs by the patients for whom the drugs are made, is good news for the cannabis industry because it helps to debunk the negative associations spread about the cannabis plant.
People are now increasingly seeing the different forms of the cannabis plant, such as hemp and marijuana, as beneficial in many different ways, and this can only expand the horizon for the CBD industry.
Experts believe that CBD industry actors like Marijuana Company of America Inc. (OTCQB: MCOAD) and Neutra Corp. (OTCQB: NTRR) hope that this drug will be affordable and help as many people as the number that has the conditions that the drug can treat.
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