뇌전증 재단(Epilepsy Foundation), Dravet 증후군 치료를 위한 첫 번째 잠재적 CBD 약 지원을 위해 FDA 자문위원회에서 증언

뇌전증 재단(Epilepsy Foundation), Dravet 증후군 치료를 위한 첫 번째 잠재적 CBD 약 지원을 위해 FDA 자문위원회에서 증언
Epilepsy Foundation Testifies Before FDA Advisory Committee in Support of Potential First-Ever Cannabidiol Drug to Treat Dravet Syndrome

 

Thursday, April 19, 2018

Washington, D.C. –

 

Epilepsy Foundation의 사장겸 CEO Philip Gattone은 오늘 미국식품의약국(FDA) 말초 및 중추신경계 약물자문위원회에서 Dravet 및 Lennox-Gastaut 증후군 치료를 위한 Epidiolex 승인을 지지한다고 증언했습니다.
뇌전증 재단은 최소 3백 4십만 명의 뇌전증과 발작 미국인을 대변하는 전국적 자발적 보건단체입니다.
자문위원 회의는 만장일치로 미국 칸나비스 식물에서 추출한 첫 약제 Epidiolex의 승인을 위해 투표를 마쳤습니다.
Epilepsy Foundation 사장 겸 CEO Philip Gattone은 "Dravet 증후군 치료제 최초의 승인을 위한 자문위원의 권고에 기뻐하고 있습니다."
지난 몇 년간 중요한 치료 발전에도 불구하고 많은 뇌전증 환자들은 발작 조절을 하지 못합니다.
Epidiolex는 난치성 발작과 희귀 뇌전증로 살아가는 많은 개인들에게 희망을 안겨주는 약입니다.
매일 심각한 도전과 불구의 발작에 직면하고 심각한 부상과 사망의 위험이 계속됩니다."
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.”

 

 

뇌전증은 다양한 정신 및 신체 기능에 영향을 미치는 발작을 일으키는 의학적 증상입니다.
미국인 26명 중 1명이 평생 동안 어느 시점에서 뇌전증을 앓게 됩니다. 뇌전증 환자들 중 3분의 1 이상이 발작 조절을 하지 못하며, 많은 사람들이 인지 기능, 기분, 기억에 영향을 미치는 유의한 부작용이 나타나기 때문에 뇌전증 공동체에서는 큰 필요를 느끼고 있습니다.

"최소한의 부작용으로 경련을 관리하려면 의사와 환자가 신중하게 평가하고 모니터링해야 합니다" 라고 Epilepsy Foundation 수석과학책임자 NYU Langone Health 종합 뇌전증센터 교수 Jacqueline French 박사는 말했습니다.
"현재 Dravet에 대한 FDA 승인 치료법은 없으며 거의 모든 Dravet 및 Lennox-Gastaut 환자가 평생 동안 통제불능 발작 및 기타 의료 요구를 계속하고 있습니다.
CBD에서 파생된 치료법은 Dravet 증후군과, Lennox-Gastaut 증후군, 결절성 경화증 복합체, Infantile Spasms 등 몇 가지 다른 희귀 뇌전증에 대한 약속을 보여줍니다."
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.”

 

칸나비노이드 전문

www.dopza.com  

돕자몰

 

Dravet 증후군은 유아기에 시작되는 드문 고도의 난치성 뇌전증 형태 입니다.
뇌전증은, 예기치 않은 갑작스런 뇌전증 사망(SUDEP) 등 조기 사망 위험이 높을 뿐만 아니라 빈발 하고 지속되는 발작, 발작 조절 불량, 발달 지연이 특징인 쇠약해지는 평생 동안의 질병입니다.
Lennox-Gastaut 증후군은 희귀병이며, 쇠약해지는 고도의 난치성 소아뇌전증 형태입니다.
Lennox-Gastaut 증후군은 여러 가지 발작 유형과 중간에서 중증의 인지 장애가 특징 입니다.
LGS 경험을 가진 사람은 통제불능 발작과 관련된 빈번한 추락 때문에 중상을 입을 위험이 높아집니다.

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.

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About Epilepsy

 

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.

“Like” the Epilepsy Foundation on Facebook at facebook.com/epilepsyfoundationofamerica and follow us on Twitter at twitter.com/epilepsyfdn.