FDA Committee Votes in Favor of Cannabidiol Oral Solution for LGS, Dravet Syndrome
GW Pharmaceuticals announced that the Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs Advisory Committee has unanimously voted to support the approval of Epidiolex (cannabidiol oral solution) for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged ≥2 years.
LGS and Dravet syndrome are rare, severe forms of childhood epilepsy. If approved, Epidiolex would mark the first purified, plant-based cannabidiol oral solution and the first in a new class of antiepileptics; it does not produce the high associated with marijuana.
The Advisory Committee reviewed data from a clinical program that included three Phase 3 randomized, controlled trials and an open-label extension study. In the Phase 3 studies, Epidiolex as adjunctive therapy to antiepileptic drugs significantly decreased the frequency of seizures in patients with LGS and Dravet syndrome. Treatment with Epidiolex was well tolerated with most adverse events being mild or moderate in nature.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) target date for June 27, 2018.
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