GW Pharma's cannabis-based Epidyolex edges closer to EU approval with positive CHMP opinion in epilepsy

UK-based biotech GW Pharmaceuticals has announced that its cannabidiol oral solution Epidyolex has secured recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). The specialist panel chose to endorse the therapy and push for its approval, in combination with clobazam, as an adjunctive treatment for seizures associated with Lennox‑Gastaut syndrome (LGS) or Dravet syndrome in patients at least two years old.

The panel came to the positive ruling based on Phase 3 evidence drawn from over 714 patients with LGS or Dravet syndrome, two treatment-resistant forms of epilepsy which can cause multiple seizures per day and present a significant burden of care.

“In my clinic, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies. These patients and their families face a long and challenging road and very few achieve adequate seizure control” said Dr Antonio Gil-Nagel Rein, Director of the Epilepsy Programme at Ruber International Hospital in Madrid. “Based on numerous clinical trials and the scrutiny of the European medicines regulator, this medicine has the potential to make a real difference to the lives of many patients.”

Justin Gover, GW’s Chief Executive Officer, also remarked: “Today’s positive CHMP opinion for Epidyolex marks a major milestone for patients, and their families, battling to control two of the most severe and life-threatening forms of childhood onset epilepsy. Cannabidiol oral solution is the first in a new class of epilepsy medicines and the first plant-derived cannabis-based medicine to be submitted for European regulatory review, representing a historic breakthrough. We are excited by the potential to bring patients and physicians a rigorously tested and evaluated cannabis-based medicine with a documented safety and efficacy profile, manufactured to the highest standards and approved by a medicines regulator.”

It was noted that, following the recommendation, the European Commission would work to come to a final decision on whether or not to approve the drug within two months. The drug was approved under the brand Epidiolex by the FDA in the same indication back in June 2018.

Matt Fellows