GWPH - European advisory group backs GW Pharma's Epidyolex in benign tumors

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion on GW Pharmaceuticals' (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 mostly causes benign tumors to grow in vital organs, including the brain, skin, heart, eyes, kidneys and lungs, and in which epilepsy is the most common neurological feature. TSC is typically diagnosed in childhood. The CHMP’s positive opinion is based on data from a positive Phase 3 study evaluating 25 mg/kg/day of GW’s cannabidiol (oral solution).A final decision by the European Commission on the application is expected in approx. two months.

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European advisory group backs GW Pharma's Epidyolex in benign tumors