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Cannabidiol with clobazam for treating seizures associated with Dravet syndrome

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2 Information about cannabidiol

Anticipated marketing authorisation indication

On 26 July 2019 the Committee for Medicinal Products for Human Use adopted a positive opinion and recommended the granting of a marketing authorisation for cannabidiol (Epidyolex, GW Pharma) for use as 'adjunctive therapy for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in conjunction with clobazam, for patients 2 years of age or older'.

Dosage in the marketing authorisation

It is administered orally as 100 mg/ml cannabidiol solution. The recommended starting dose is 2.5 mg/kg taken twice daily for 1 week. After 1 week, the dose should be increased to a maintenance dose of 5 mg/kg twice daily (10 mg/kg/day). Based on individual clinical response and tolerability, each dose can be further increased in weekly increments of 2.5 mg/kg taken twice daily up to a maximum recommended dose of 10 mg/kg twice daily (20 mg/kg/day). Any dose increases above 10 mg/kg/day should take into account individual benefit and risk.

Price

The company has not confirmed the list price with the Department of Health and Social Care. The proposed list price is considered confidential by the company.