Epidiolex is a standardized, plant-derived Cannabidiol (CBD) extract formulated by GW Pharmaceuticals, a company that originates in England and also has offices located in California. The US Food and Drug Administration will undertake a “priority review” of data specific to the safety and efficacy of this new drug which should be completed by June 27, 2018.
A priority review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapies exist. The granting of priority review for the Epidiolex NDA accelerates the timing of the FDA review of the application compared to a standard review.
Epidiolex is used to treat children with treatment-resistant conditions of childhood onset epilepsy such as Lennox-Gastaut Syndrome and Dravet Syndrome. Currently there are no FDA approved medications that treat Dravet Syndrome.
The annual cost of this medication if given FDA approval should be $30K-$60K, according to analysts.