GW Pharmaceuticals receives European Commission approval for Epidyolex for seizures

The European Commission has approved the marketing authorization for marijuana-based Epidyolex (cannabidiol) for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients aged two years and older.

The approval paves the way for the launch of the medicine across Europe, says the drug’s developer UK-based GW Pharmaceuticals (Nasdaq: GWPH), whose shares were up 3.86% to $133.90 in pre-market trading.

“The approval of Epidyolex marks a significant milestone, offering patients and their families the first in a new class of epilepsy medicines and the first and only EMA-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” said Justin Gover, GW’s chief executive, adding: “This approval is the culmination of many years of dedication and collaboration between GW, physicians and the epilepsy community. 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.”