- The European Commission has approved GW Pharmaceuticals' (NASDAQ:GWPH) Type II variation application for EPIDYOLEX (cannabidiol) as an adjunctive treatment of seizures associated with tuberous sclerosis complex(TSC), for patients two years of age and older.
- TSC, a rare genetic condition, mostly causes benign tumours to grow in vital organs of the body, and in which epilepsy is the most common neurological feature.
- The approval is based on data from a positive Phase 3 safety and efficacy study evaluating 25 mg/kg/day of GW’s cannabidiol.
- This approval represents the third indication for GW’s cannabidiol in Europe.