GW Pharmaceuticals has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for a new indication for its CBD-based epilepsy medicine Epidyolex.
The new indication sees Epidyolex approved as an adjunctive treatment of seizures associated with tuberous sclerosis complex (TSC), which causes epilepsy in up to 85% of patients, with many not responding to standard anti-seizure medicines.
Originally the medicine was approved as an adjunctive therapy, in conjunction with clobazam, for seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome for patients aged two years and older.
This new approval for TSC is the fourth approved indication of a cannabis-based medicine in the UK for GW pharmaceuticals, which executive vice president Chris Trovey said “represents a significant step forward for TSC patients in the UK, many of whom may benefit from this new treatment”.
The approval is based on data from a phase 3 safety and efficacy study that evaluated Epidyolex. The findings saw a reduction in seizure frequency of 49% in patients taking the medicine everyday, compared to 27% for a placebo.
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.”
It is estimated that between 3,700 and 11,000 people in the UK live with TSC, which is a condition that causes mostly benign tumours to grow in vital organs in the body, with epilepsy being the most common neurological feature.
In May, Epidyolex was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) for patients with Dravet Syndrome.