Washington, D.C. – Philip Gattone, President and CEO of the Epilepsy Foundation, along with other epilepsy advocates, today testified at the U.S. Food & Drug Administration’s (FDA) Peripheral and Central Nervous System Drug Advisory Committee in support of approval of Epidiolex for the treatment of Dravet and Lennox-Gastaut syndromes. The Epilepsy Foundation is the leading national voluntary health organization that speaks on behalf of the at least 3.4 million Americans with epilepsy and seizures. The Advisory Committee concluded with a unanimous vote to recommend approval of Epidiolex, the first drug derived from cannabis plant in the U.S.
“We are pleased by the advisory committee’s recommendation to approve the first drug ever for the treatment of Dravet syndrome,” said Philip Gattone, President and CEO, Epilepsy Foundation. “Despite significant therapeutic advances in the last few years, many individuals living with epilepsy do not achieve seizure control. Epidiolex represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death.”
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Approximately 1 in 26 Americans will develop epilepsy at some point in their lifetime. There is a great unmet need in the epilepsy community, as more than a third of people living with epilepsy do not have seizure control, and many more live with significant side-effects that impact cognitive ability, mood, and memory.
“Managing seizures with minimal side effects requires careful evaluation and monitoring by physicians and their patients,” said Jacqueline French, M.D., Chief Scientific Officer of the Epilepsy Foundation and Professor of Neurology, NYU Langone Health’s Comprehensive Epilepsy Center. “There are currently no FDA-approved treatments for Dravet, and nearly all individuals with Dravet and Lennox-Gastaut continue to have uncontrolled seizures and other medical needs throughout their lifetime. Therapies derived from cannabidiol (CBD) show promise for these patients with Dravet syndrome, and several other rare epilepsies, such as Lennox-Gastaut syndrome, Tuberous Sclerosis Complex, and Infantile Spasms.”
Dravet syndrome is a rare and catastrophic form of intractable epilepsy that begins in infancy and is highly treatment-resistant. It is a debilitating, life-long condition characterized by frequent and prolonged seizures, poor seizure control, and developmental delays, as well as an increased risk of premature death including sudden unexpected death in epilepsy (SUDEP).
Lennox-Gastaut syndrome is a rare and often debilitating form of childhood-onset epilepsy that is highly treatment-resistant. It is characterized by multiple seizure types, and moderate to severe cognitive impairment. Individuals living with LGS experience an increased risk of serious injury because of frequent falls associated with uncontrolled seizures.
When a person has two unprovoked seizures or one unprovoked seizure with the likelihood of more, they are considered to have epilepsy. (An unprovoked seizure is one that occurs for no known reason.) Epilepsy affects more than 3.4 million people in the U.S. and 65 million worldwide. This year, another 150,000 people will be diagnosed with epilepsy. Despite all available treatments, at least 3 out of 10 people with epilepsy continue to experience uncontrolled seizures while many more experience less than optimal seizure control.
About the Epilepsy Foundation
The Epilepsy Foundation, a national non-profit with over 50 local organizations throughout the U.S., has led the fight against seizures since 1968. The Foundation is an unwavering ally for individuals and families impacted by epilepsy and seizures. The mission of the Epilepsy Foundation is: to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives. The Foundation works to ensure that people with seizures have the opportunity to live their lives to their fullest potential. For additional information, please visit epilepsy.com.
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