EC Clears Cannabidiol for Severe Forms
of Epilepsy

Deborah Brauser

September 23, 2019

The European Commission (EC) has approved the add-on use of cannabidiol oral solution (Epidyolex, GW Pharmaceuticals) for treating seizures associated with two severe forms of epilepsy, the manufacturer reports.

The indication for the drug in the EC's marketing authorization is for use as adjunctive therapy with clobazam (multiple brands) in patients ages 2 and older who have Lennox-Gastaut syndrome (LGS) or Dravet syndrome.

As reported by Medscape Medical News, the European Medicine's Agency's (EMA's) Committee for Medicinal Products for Human Use recommended approval for the drug in July.

A year earlier, the US Food and Drug Administration approved GW's same version of the drug under the name Epidiolex — making it the first cannabis drug approved by the agency. The EC's approval also marks its first for a plant-derived cannabis-based medication.

The new approval "is an important milestone for patients and families whose lives are significantly impacted by these rare, complex, and life-long forms of epilepsy," Isabella Brambilla, chairperson of the Dravet Syndrome European Federation, said in a press release from the manufacturer.

"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," Brambilla added.

Based on Four Trials

LGS and Dravet syndromes "are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy, with few patients achieving adequate seizure control," Elinor Ben-Menachem, MD, PhD, professor at the University of Goteborg, Sahlgren Academy and Hospital, Sweden, said in the same release.

The EC's approval was based on four phase 3 trials that included more than 714 total patients with one of these two syndromes. Results showed that cannabidiol plus other anti-epileptic therapies significantly reduced the frequency of seizures vs placebo.

Somnolence, diarrhea, pyrexia/fever, fatigue, vomiting, and decreased appetite were the most common treatment-related adverse events.

"The EMA approval of Epidyolex will bring hope to patients and families, with the potential to better control seizures and improve quality of life," Ben-Menachem noted.

The new approval will allow marketing of the drug in all 28 European Union countries, plus Norway, Iceland, and Liechtenstein, the company reported.

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