GW Pharma’s Epidyolex scores new EU indication

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 ...

• Source: drugdu
• 234
• April 21, 2021