European Union Approves First Cannabis-based Medicine Epidyolex

The European Union has approved a cannabidiol or CBD-based medicine for treatment of seizures associated with severe forms of epilepsy. Epidyolex, a CBD oral solution, is the first cannabis-based medicine to be approved by the European Medicines Agency or EMA.

The EU decision is valid in all 28 countries of the European Union, alongside Norway, Iceland and Liechtenstein. The approval paves the way for the launch of the medicine across Europe.

CBD is a naturally-occurring cannabinoid constituent of cannabis. It is a chemical in the marijuana plant often used for medicinal purposes, and does not have the intoxicating effects like those caused by tetrahydrocannabinol or THC.

GW Pharmaceuticals plc said in a statement that the European Commission or EC approved the marketing authorization for Epidyolex as an adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, an existing treatment for epilepsy.

The medicine is approved for patients aged two years of age and older. LGS and Dravet syndrome are two rare forms of epilepsy with high morbidity and mortality rates.

Epidyolex's approval by the EMA is based on results from four randomised, controlled Phase 3 trials. These studies incorporated data from more than 714 patients with either LGS or Dravet syndrome.

Many patients with LGS or Dravet syndrome have multiple seizures per day, which puts them at ongoing risk of falls and injury. Despite current anti-epileptic drug treatment, both of these severe forms of epilepsy remain highly treatment-resistant.

Epidyolex significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome, when added to other anti-epileptic therapies, according to GW Pharmaceuticals.

"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, Chief Executive Officer of GW Pharmaceuticals.

In June 2018, GW Pharmaceutical's cannabidiol oral solution was approved by the U.S. Food and Drug Administration or FDA in June 2018 under the trade name Epidiolex for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age or older. This was for the first time the FDA approved a cannabis plant-derived, CBD-based drug.

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