GW Pharmaceuticals granted orphan designation by the EMA for Epidiolex

Cannabinoid product specialist GW Pharmaceuticals (Nasdaq: GWPH) has been granted orphan designation by the European Medicines Agency for its investigational product Epidiolex (cannabidiol) in the treatment of Dravet syndrome, a rare and treatment-resistant form of childhood epilepsy.

It has also been granted fast track designation by the US Food and Drug Administration for Epidolex in treating Dravet syndrome, and orphan designations for Dravet syndrome and Lennox-Gastaut syndrome. The company is about to commence a full clinical development program for Epidiolex in the treatment of both illnesses. The first Phase II/III trial is due to begin in the coming weeks for Epidolex in treating Dravet syndrome, and orphan designations for Dravet syndrome and Lennox-Gastaut syndrome. The company is about to commence a full clinical development program for Epidiolex in the treatment of both illnesses. The first Phase II/III trial is due to begin in the coming weeks.

GW has announced physician reports of Epidiolex treatment in children and young adults from open-label ‘expanded access’ studies showing a median overall reduction in convulsive seizure frequency of 51%-72% across a range of time points and analyses in patients with Dravet Syndrome.