GW Pharmaceuticals PLC's cannabis-based epilepsy medicine Epidyolex has been approved by the European Commission to treat seizures in patients with rare childhood epilepsy conditions Dravet and Lennox-Gastaut syndromes.
Epidyolex will now be marketed across Europe to treat seizures associated with the two severe types of epilepsy in patients two years and older, the company said in a Sept. 23 press release. The drug is to be paired with clobazam, a generic drug commonly used to treat seizures in children.
Dravet syndrome is a highly treatment-resistant form of epilepsy that typically develops in previously healthy infants before they turn two. The patients are prone to bouts of prolonged seizures and face a risk of premature death. Lennox-Gastaut syndrome occurs between the ages of 3 and 5 due to a number of conditions, including brain malformations or severe head injuries. These patients face multiple seizure types.
The approval of GW Pharma's cannabidiol oral therapy is based on results from four late-stage clinical trials featuring more than 714 patients with either Lennox-Gastaut or Dravet syndrome. During the trials, Epidyolex was found to reduce the frequency of seizures when added to other epilepsy treatment regimens.
The Cambridge, England-based drugmaker secured U.S. approval in June 2018 for the same indication, becoming the first U.S. Food and Drug Administration-approved treatment for Dravet syndrome. The drug is marketed as Epidiolex in the U.S. Since launching the drug, GW Pharma has faced challenges with distribution and insurance coverage.
Epidyolex received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in July, which is a recommendation for approval by the European Commission. However, the U.K.'s National Institute for Health and Care Excellence did not recommend the drug in August due to uncertainty about Epidyolex's long-term effectiveness, as GW Pharma's clinical trials for Epidyolex lasted just 14 weeks.
