Posted by Michael Wonder on 01 Apr 2020
GW Pharmaceuticals and Greenwich Biosciences announce FDA acceptance of sNDA filing with priority review for Epidiolex (cannabidiol) in the treatment of seizures associated with tuberous sclerosis complex
31 March 2020 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently submitted supplemental new drug application for the use of Epidiolex (cannabidiol) to treat seizures associated with tuberous sclerosis complex.
The PDUFA goal date for completion of the FDA review of the Epidiolex sNDA is 31 July 2020.
Epidiolex is already approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy.
