GW Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for filing with Priority Review the New Drug Application (NDA) for Epidiolex (cannabidiol) as treatment for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
Lennox-Gastaut syndrome and Dravet syndrome are two rare conditions of childhood-onset epilepsy. Lennox-Gastaut syndrome commonly occurs between ages 3 to 5 years and Dravet syndrome typically occurs during the first year of life. Acceptance under Priority Review allows for accelerated timing of the application review vs a standard review. The FDA stated in its letter that it will hold an advisory committee meeting to discuss the application.
Epidiolex is an investigational drug candidate developed from purified cannabidiol. The Company is also evaluating other clinical development programs in other orphan seizure disorders including Phase 3 trials in Tuberous Sclerosis Complex and Infantile Spasms.
The Prescription Drug User Fee Act (PDUFA) goal date for FDA review is set for June 27, 2018.
GW pharmaceuticals announces acceptance of NDA filing for Epidiolex® (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome [press release]. London, UK: GW Pharmaceuticals. Published December 28, 2017. Accessed January 3, 2018.
This article originally appeared on MPR