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
About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution, CV, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX®. The Company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.
About EPIDIOLEX® (cannabidiol) oral solution, CV
EPIDIOLEX® (cannabidiol) oral solution, CV, a pharmaceutical formulation of highly purified cannabidiol (CBD), is the first in a new class of anti-epileptic medications with a novel mechanism of action, and the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA). In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. A supplemental New Drug Application (sNDA) has been submitted to the FDA for the treatment of seizures associated with tuberous sclerosis complex (TSC). Epidiolex has received approval in the European Union under the tradename EPIDYOLEX® for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and Dravet syndrome. Epidiolex/Epidyolex has received Orphan Drug Designation from the FDA and the EMA for the treatment of seizures associated with Dravet syndrome, LGS and TSC, each of which are severe childhood-onset, drug-resistant syndromes.
Important Safety Information
Important safety information for Epidiolex is available at Epidiolex.com.
This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding our goal of bringing Epidiolex® to patients with seizures associated with Tuberous Sclerosis Complex (TSC), the potential for Epidiolex to serve as a new treatment option for patients with seizures associated with TSC, the clinical benefits of Epidiolex, and the timing and outcomes of regulatory decisions. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the risks and uncertainties which can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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1 TS Alliance, What is TSC? https://www.tsalliance.org/about-tsc/what-is-tsc/. Accessed April 15, 2019.
2 NIH Tuberous Sclerosis Fact Sheet. https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Tuberous-Sclerosis-Fact-Sheet. Accessed November 19, 2019.
3 TS Alliance Website. https://www.tsalliance.org/. Accessed November 19, 2019.
4 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157.
5 Kwan P., Brodie M.J. Early identification of refractory epilepsy. N. Engl. J. Med. 2000;342(5):314–319.
6French JA. Refractory epilepsy: clinical overview. Epilepsia. 2007;48 Suppl 1:3-7.