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 ComplexPDUFA

GW Pharmaceuticals Ltd. plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with its U.S. subsidiary Greenwich Biosciences, Inc., today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted supplemental New Drug Application (sNDA) for the use of  EPIDIOLEX^® (cannabidiol) CV to treat seizures associated with Tuberous Sclerosis Complex (TSC). The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the EPIDIOLEX sNDA is July 31, 2020. EPIDIOLEX is already approved for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy.

“We are pleased with the FDA’s acceptance of our EPIDIOLEX sNDA filing with Priority Review, an action that underscores the unmet need for new treatment options for patients with TSC, a rare and severe childhood-onset disease,” said Justin Gover, GW’s Chief Executive Officer. “More than 60% of individuals with TSC do not achieve seizure control with standard anti-epileptic drug treatments. Today’s news is therefore important for TSC patients and their clinicians, and we look forward to working with the FDA during the review process to expand the EPIDIOLEX product label for use in TSC.”

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 sNDA accelerates the timing of the FDA review of the application to a six month period compared to a standard review of ten months.

–Bio Space