GW Pharmaceuticals receives approval for Epidyolex from the MHRA

GW was initially granted marketing authorisation for this medicine in the UK in September 2019 as an adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older. GW also received positive recommendation from the UK's National Institute for Health and Care Excellence (NICE) for this medicine in November 2019 to receive routine reimbursement from NHS England. This authorisation for TSC, represents the fourth approved indication of a cannabis-based medicine in the UK for GW and underlines GW's commitment to the UK and regulatory approved cannabis-based medicines.

The approval, made through the European Commission Decision Reliance Procedure (ECDRP), 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. GW's development programme represents the only well-controlled clinical evaluation of a cannabinoid medication for patients with refractory epilepsy..