Europe approves marketing of Epidiolex

The European Commission a approuvé marketing authorization (MA) for Epidyolex, the European name for Epidiolex, as an adjunctive treatment for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, combined with clobazam, in patients aged two years and over.

The cannabis-based medicine can now be sold throughout Europe and in the UK. The unfortunate would say «except in France», in view of to the complicated history of Sativex, but Epidiolex is already prescribed and distributed under ATU, This is in contrast to Sativex, which has never been legally available to French patients.

Epidiolex / Epidyolex is a 100mg/mL natural CBD drinking solution with a sesame oil base and strawberry flavor.

«The approval of Epidyolex marks a significant milestone and offers patients and their families the first example of a new class of epilepsy drugs and the first and only CBD-based medicine approved by the European Medicines Agency (EMA) to treat two forms of severe, life-threatening epilepsy,» said Justin Gover, CEO of GW Pharmaceuticals. «This approval is the result of many years of dedication and collaboration between GW, physicians and the epilepsy community. We believe that patients and physicians deserve access to rigorously tested and evaluated cannabis-based medicines, manufactured to the highest standards and approved by drug regulatory authorities. We're delighted to be the first to bring this solution to the world of epilepsy.»

Epidiolex has just received European marketing authorization based on the results of four Phase III randomized controlled trials. These clinical studies incorporate data from over 714 patients with LGS or Dravet syndrome, two rare forms of epilepsy characterized by high morbidity and mortality rates, and which place a significant burden on families and caregivers. Many patients with LGS or Dravet syndrome have several seizures a day, putting them at constant risk of falls and injury. Despite current antiepileptic drug treatment, these two severe forms of epilepsy remain highly resistant to treatment.

Combined with other antiepileptic treatments, Epidyolex has considerably reduces the frequency of epileptic seizures in patients with LGS and Dravet syndrome. The most common adverse effects observed in patients treated with the drug were somnolence, loss of appetite, diarrhea, pyrexia, fatigue and vomiting. GW's development program represents the only controlled clinical evaluation of a drug based on cannabinoids for patients with LGS and Dravet syndrome.

Epiodiolex has been approved by the Food and Drug Administration American in June 2018 for the treatment of seizures associated with LGS or Dravet syndrome in patients aged 2 and over. The Drug Enforcement Administration (DEA) has given the green light to Epidiolex just three months after its approval by the US regulator.

The treatment is sold for $32,500 a year in the United States, a price comparable to that of other epilepsy products on the market. Indications for reimbursement are not yet known.

Epidiolex and Epidyolex are both produced in the UK.