A company developing drugs derived from cannabis has won approval for its epilepsy medicine in Europe.
Cambridge, U.K.-based GW Pharmaceuticals said Monday that the European Commission approved Epidyolex (cannabidiol) as an adjunctive therapy for seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, both of which are severe and life-threatening forms of childhood-onset epilepsy. The approval is for patients aged 2 and older, and Epidyolex is meant to be used with another drug, clobazam.
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The drug won Food and Drug Administration approval last year for the same indication in the U.S., where it is marketed as Epidiolex. The EC approval encompasses all 28 countries of the European Union, as well as the European Economic Area nations of Norway, Iceland and Liechtenstein.
“This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community,” GW CEO Justin Gover said in a statement. “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.”
Shares of GW were down about 7 percent on the Nasdaq in the early afternoon Tuesday.
The company noted that the approval is based on data from four randomized, controlled Phase III trials that enrolled a total of 714 patients. In May, the company announced data from another Phase III study, among patients with tuberous sclerosis complex, another rare and severe form of childhood-onset eiplepsy. The data showed that the drug, administered at 25mg and 50mg per kilogram of body weight daily, reduced seizures by 48.6 percent and 47.5 percent, respectively.
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Epidyolex is an oral solution containing a highly purified form of cannabidiol, or CBD, which comes from cannabis but lacks the ability to cause intoxication that is associated with cannabis.
Under U.S. Drug Enforcement Administration regulations, Epidiolex is under Schedule V, the least restrictive schedule of the Controlled Substances Act. However, marijuana-derived CBD generally remains illegal under federal law, except in instances – as with Epidiolex – when it has been determined to have a medical benefit. Several states have moved to legalize marijuana for recreational use as well.
Photo: Ethan Miller, Getty Images
