EMA Panel Backs Cannabis Drug for Severe Epilepsy

Megan Brooks

Disclosures

July 26, 2019

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of cannabidiol oral solution (Epidyolex, GW Pharma) as add-on therapy for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in conjunction with clobazam (multiple brands) for patients as young as 2 years.

The US Food and Drug Administration (FDA) approved GW's cannabidiol oral solution last year under the trade name Epidiolex, as reported by Medscape Medical News.

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

The CHMP's positive opinion is based on results from four randomized, controlled phase 3 trials that included 714 patients with either LGS or Dravet syndrome. Results showed that add-on therapy with the cannabidiol product was more effective than placebo in reducing seizure frequency.

"This is a significant milestone for patients with LGS and Dravet syndrome as there remains a severe unmet medical need for these rare, lifelong forms of epilepsy," Martin Brodie, MD, president of the International Bureau for Epilepsy, said in a news release from the drugmaker.

"Today's positive opinion brings hope to both patients and their families of a treatment option which has the potential to better control seizures and notably improve quality of life," Brodie said.

"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," added Antonio Gil-Nagel Rein, MD, director of the epilepsy program, Ruber International Hospital, Madrid, Spain, said in the release.

"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," he said.

The most common side effects are somnolence, decreased appetite, diarrhea, pyrexia, fatigue, and vomiting. Epidyolex will be available as a 100-mg/mL oral solution.

Detailed recommendations for the use of Epidyolex will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

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