A US FDA Advisory Committee has unanimously voted to support the approval of a plant-based cannabidiol formulation for the adjunct treatment of seizures associated with two severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome, in patients 2 years of age and older. LGS and Dravet syndrome both develop in childhood, and most patients experience multiple seizures per day. If approved, the investigational formulation of cannabidiol (Epidiolex, developed by GW Pharmaceuticals) would be the first approved medication for the treatment of Dravet syndrome. Epidiolex has received Orphan Drug Designation for the treatment of Dravet syndrome and LSG as well as for tuberous sclerosis complex (TSC) and infantile spasms (IS), and has received Fast Track Designation for the treatment of Dravet syndrome. The recommendations of the Advisory Committee are based on the results of three Phase III clinical trials and an open-label extension trial, which showed that Epidiolex added to existing anticonvulsant treatment significantly reduced the frequency of seizures in patients with LGS and Dravet syndrome, with mild to moderate adverse effects.
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