GW Pharmaceuticals’ Epidyolex has received approval from the European Commission (EC) for the treatment of seizures associated with tuberous sclerosis complex (TSC) – its third indication in Europe.
Specifically, Epidyolex (cannabidiol) has been approved as an adjunctive treatment of seizures associated with TSC for patients aged two years and older.
TSC is a rare genetic condition that causes mostly benign tumours to grow in vital organs including the brain, skin, heart, eyes, kidney and lungs.
The condition is typically diagnosed in childhood and the most common neurological feature in TSC is epilepsy. It is also associated with an increased risk of autism and intellectual disability, although the severity of the condition can vary widely.
The EC approval is based on data from a Phase III trial evaluating Epidyolex for the treatment of seizures associated with TSC.
This study hit its primary endpoint of reduction in seizure frequency, with seizure reduction of 49% in patients taking Epidyolex 25 mg/kg per day compared with 27% for placebo.
The safety profile observed in the study was also consistent with findings from previous trials, with no new safety risks identified.
“We are excited by the news of this approval by the European Commission and the benefits Epidyolex could bring to the community. The clinical data supporting Epidyolex in TSC provides hope of a better quality of life for patients,” said Volker Knappertz, chief medical officer of GW Pharma.
“This medicine provides more choice for physicians managing seizures associated with TSC and has the potential to benefit the thousands of patients who do not respond to the current standard of care,” he added.
Epidyolex is already approved in the EU as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome (LGS) or Dravet syndrome, alongside clobazam, for patients aged two years and older.