The only federally approved CBD product in the U.S. has been OK’d by European authorities for use there.
The European Commission granted marketing authorization to Epidyolex, the trade name in Europe for Epidiolex, GW Pharmaceuticals announced Monday.
In June 2018, the U.S. Food and Drug Administration approved Epidiolex for the treatment of seizures associated with two rare kinds of epilepsy.
The CBD-based medicine was greenlighted in Europe also for the treatment of the same conditions – Lennox-Gastaut syndrome (LGS) or Dravet syndrome – in conjunction with clobazam.
Sativex, another cannabis-derived GW product which is available in several European countries, does not have European-wide approval.
In the first quarter of 2019, Sativex had 15% market share of Germany’s insurance-covered medical cannabis sales.
The centralized approval of Epidiolex paves the way for a launch across all EU member states, as well as in the European Economic Area.
According to the European Medicines Agency, fewer than 26,000 patients are affected by Dravet syndrome and about 103,000 are afflicted with LGS across the region.
Two months ago, the European Committee for Medicinal Products for Human Use (CHMP) recommended approval of Epidiolex, but the final decision was up to the European Commission.
Normally, European countries that allow the prescription of medical cannabis without proven efficacy do so only after prioritizing the prescription of medicines with marketing authorization.
For GW Pharmaceuticals, this means Epidiolex will have an advantage over other companies selling medical cannabis products without marketing authorization or proven efficacy by clinical trials.