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 Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older.
The CBD-based medicine was greenlighted in Europe also for the treatment of the same conditions, in conjunction with clobazam.
Sativex, another 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.
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.
The decision for the CBD oral solution was “based on results from four randomised, controlled Phase 3 trials,” GW said in a press release.
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.