GW Pharma’s Epidyolex scores new EU indication
21st April 2021
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.
GW Pharmaceuticals plc: GW Pharmaceuticals receives European Commission approval for EPIDYOLEX (cannabidiol) for the treatment of seizures associated with tuberous sclerosis complex
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LONDON, April 20, 2021 (GLOBE NEWSWIRE) GW Pharmaceuticals plc (Nasdaq: GWPH) ( GW , the Company or the Group ), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the European Commission (EC) has approved the Type II variation application for EPIDYOLEX (cannabidiol) as an adjunctive treatment of seizures associated with TSC, for patients two years of age and older. This approval, which represents the third indication for GW s cannabidiol in Europe, paves the way for the expanded launch of the medicine across Europe.