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

PDUFA date of July 31, 2020

CARLSBAD, Calif., March 31, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals 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.

About Tuberous Sclerosis Complex (TSC)
Tuberous sclerosis complex (TSC) is a rare genetic condition that affects approximately 50,000 individuals in the U.S. and nearly one million people worldwide.¹ At least two children born each day will develop TSC, with an estimated prevalence of one in 6,000 newborns.⁵ The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs ² and is a leading cause of genetic epilepsy.³ TSC often occurs in the first year of life as either focal seizures or infantile spasms¹ and is associated with an increased risk of autism and intellectual disability.⁴ The severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.⁶ Epilepsy is present in about 85% of patients with TSC and may progress to become intractable to medication.^1,2,3 More than 60% of individuals with TSC do not achieve seizure control⁴ with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation² compared to 30-40 percent of individuals with epilepsy who do not have TSC who are drug resistant.^5,6