Jazz Pharmaceuticals subsidiary GW Pharmaceuticals has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its cannabidiol Epidyolex as an adjunctive treatment of seizures associated with tuberous sclerosis complex (TSC), for patients aged two years and older.
The developer of cannabis-based medicines was initially granted marketing authorisation for Epidyolex in the UK in September 2019 as adjunctive therapy for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome, in conjunction with clobazam, for patients aged two years and older. GW also received a positive NICE recommendation for the medicine in this indication.
The TSC authorisation is the fourth approved indication of cannabis-based medicine in the UK for GW, the company said in a statement.
Commenting on the MHRA approval of Epidyolex, Tuberous Sclerosis Association (TSA) chief executive Louise Fish said: “One in every two people living with TSC-related epileptic seizures has difficult to treat epilepsy that does not respond to traditional anti-epileptic drugs. We are excited to see this new medicine approved by the MHRA, which gives people living with TSC and their families hope. We desperately need further options for clinicians who are managing seizures associated with TSC, and we, therefore, welcome this decision by the MHRA.”
The approval is based on data from a positive Phase III study, which showed a reduction in seizure frequency compared to baseline of Epidyolex vs placebo, with seizure reduction of 49% in patients taking Epidyolex 25 mg/kg/day compared with 27% for placebo.
The approval follows the recent approval of the product in all 27 countries of the European Union, alongside Norway, Iceland and Liechtenstein (including Northern Ireland).