GW Pharmaceuticals received marketing authorization from the European Commission (EC) for Epidyolex (cannabidiol (CBD)). The treatment is approved as an adjunctive therapy for seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, in patients of two years of age and older.
As a result of the approval, the treatment becomes the first plant-derived, cannabis-based medicine to be approved in Europe.
The approval process has not been a straightforward task for GW Pharma. In the US, the drug had to be reviewed by the Drug Enforcement Agency (DEA), as the agency regards cannabis as having no medical benefit due to its status as a Schedule I drug.
To allow patients to access the medicine, the DEA rescheduled the individual treatment to a Schedule V drug – a substance with the least potential for abuse.
The roll-out process in the European Union (EU) will also not be straightforward, as individual member states have different scheduling for the treatment. However, the company’s chief operating officer, Chris Tovey, has previously outlined that, upon approval in the EU, the company would focus on five major markets in the region.
In terms of capacity for the commercialization stage in Europe, the company’s CEO, Justin Gover, previously said, “At this point in time, looking at the US and Europe…we are comfortably ahead of where we would need to be, even on the most aggressive of demand forecast.”
One difference that has been made in the launch process between the US and Europe has been on the name of the product: in the US, the product is known as Epidiolex but, in its announcement of approval, it was revealed that the product will be known as Epidyolex in the European market – a change from its application for marketing approval in the region.