Cannabidiol gains MHRA approval as adjunctive treatment of seizures
pharmafile | August 11, 2021 | News story | Research and Development |
GW Pharmaceuticals has announced that is 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 Jazz Pharmaceuticals subsidiary was initially granted marketing authorisation for Epidyolex 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 aged two years and older. GW also received a positive NICE recommendation for the medicine in this indication.
This MHRA approval brings the total of cannabis-based GW products avialbale in the UK to four, the company said in a statement.
Louise Fish, Tuberous Sclerosis Association (TSA) Chief Executive, 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).
Kat Jenkins
