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Epidiolex® Approved for Seizures Associated with Lennox-Gastaut Syndrome

BOHEMIA, N.Y., June 25, 2018 (LGS Foundation) – The LGS Foundation is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX® (cannabidiol / CBD) for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients two years age or older. EPIDIOLEX® is the first prescription pharmaceutical formulation of highly-purified CBD and the first in its class of anti-epileptic drugs.

“Today’s announcement gives individuals with Lennox-Gastaut Syndrome and their families much-needed hope,” says LGS Foundation executive director, Christina SanInocencio. “Lennox-Gastaut Syndrome is a devastating form of epilepsy, and despite currently available FDA-approved medications and a poly-therapy approach to treatment, the majority of individuals with LGS will continue to have life-long, debilitating seizures, along with cognitive impairment and an abnormal EEG (electroencephalogram).”

Cannabidiol (CBD) is a compound derived from the cannabis plant that does not produce a “high” and has been an increasing focus of medical research in epilepsy. Recently, study results from the clinical trial of EPIDIOLEX® published in the New England Journal of Medicine showed to significantly reduce the number of seizures in patients with Lennox-Gastaut Syndrome.[i]

Along with the FDA’s approval for EPIDIOLEX® for seizures associated with Lennox-Gastaut Syndrome, the approval is also indicated for another form of rare epilepsy that begins in childhood called Dravet Syndrome.

“We are very pleased to see the approval of EPIDIOLEX® for Dravet and Lennox-Gastaut Syndromes, says Dravet Syndrome Foundation executive director Mary Anne Meskis. “While each of our disorders are different in terms of etiology, both of our communities suffer from intractable seizures, an increased risk of mortality, and many devastating co-morbid conditions that significantly affect quality of life.”

Anup Patel, M.D., Chair of the LGS Foundation’s Professional Advisory Board and Chief of Neurology at Nationwide Children’s Hospital, says “I am very pleased to see the FDA’s approval of EPIDIOLEX® for LGS and Dravet Syndromes. These patient populations desperately need new treatment options to help control their seizures, and the results of the clinical trial in both disorders are very promising.”

Rescheduling by the DEA is expected to occur within 90 days. Access is expected to be similar to other branded AEDs and EPIDIOLEX® is expected to be available to appropriate patients by Fall 2018. Outside the U.S., this medicine is currently under review by the European Medicines Agency (EMA) for the treatment of seizures associated with LGS and Dravet Syndrome. An EMA decision on whether to recommend approval is expected in the first quarter of 2019.

For press inquiries, please contact info@lgsfoundation.org

[1] Devinsky O, Patel AD, Cross JH, et al. Effect of Cannabidiol on Drop Seizures in the Lennox–Gastaut Syndrome. N Engl J Med 2018;378;20:1888-97