EC Approves Plant-Derived Cannabis-Based Medicine to Treat Epileptic Seizures

The European Commission has approved the first plant-derived cannabis-based medicine for the treatment of seizures in patients suffering from two rare, severe forms of childhood-onset epilepsy.

Epidyolex (cannabidol, CBD) from GW Pharmaceuticals is an oral adjunctive therapy to be used in the treatment of seizures in patients with Lennox Gastaut syndrome (LGS) or Dravet syndrome. As per the market authorization, the treatment should be used in conjunction with clobazam in patients aged two years and older.

“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 [European Medicines Agency]-approved CBD medicine to treat two severe and life-threatening forms of childhood-onset epilepsy,” said Justin Gover, GW’s chief executive officer in a Sep. 23, 2019 press release. “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.”

“The approval of cannabidiol oral solution is an important milestone for patients and families whose lives are significantly impacted by these rare, complex, and life-long forms of epilepsy,” added Isabella Brambilla, chairman, Dravet Syndrome European Federation, in the press release. “We are very happy that patients will now have access to a much-needed, new treatment option, and one routed through a rigorous clinical trials program and licensed by the EMA.”

“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy, with few patients achieving adequate seizure control,” said Professor Elinor Ben-Menachem, University of Goteborg, Sahlgren Academy and Hospital in Sweden. “The EMA approval of Epidyolex will bring hope to patients and families, with the potential to better control seizures and improve quality of life.”

Source: GW Pharmaceuticals