European Commission approves Epidyolex for the treatment of seizures associated with tuberous sclerosis complex – GW Pharma/Jazz Pharma

GW Pharmaceuticals plc announced that the European Commission (EC) has approved the Type II variation application for Epidyolex (cannabidiol) as an adjunctive treatment of seizures associated with TSC, for patients two years of age and older. This approval, which represents the third indication for GW’s cannabidiol in Europe, paves the way for the expanded launch of the medicine across Europe.

The approval is based on data from a positive Phase III safety and efficacy study evaluating 25 mg/kg/day of GW’s cannabidiol. The study met its primary endpoint, which was the reduction in seizure frequency compared to baseline of cannabidiol vs placebo, with seizure reduction of 49% in patients taking cannabidiol 25 mg/kg/day compared with 27% for placebo (p=0.0009). All key secondary endpoints were supportive of the effects on the primary endpoint. The safety profile observed was consistent with findings from previous studies, with no new safety risks identified.