SILVER SPRING, Md., July 31, 2020 /PRNewswire/ -- Today, the Tuberous Sclerosis Alliance (TS Alliance) lauds the U.S. Food and Drug Administration's (FDA's) approval of Epidiolex® oral solution to treat seizures in people one year of age and older who have tuberous sclerosis complex (TSC). Affecting approximately 50,000 in the United States and 1 million worldwide, TSC is a genetic disorder that causes non-cancerous tumors to form in vital organs; it's also the leading genetic cause of both epilepsy and autism.
"Up to 85 percent of those affected by TSC experience seizures at some point in their lifetime," explained TS Alliance President & CEO Kari Luther Rosbeck. "Unfortunately, existing medications don't always effectively control them. Our organization and the TSC community certainly welcome a new option such as Epidiolex, which is the second FDA-approved drug specific to TSC."
Manufactured by GW Pharmaceuticals and distributed in the United States by Greenwich Biosciences, Epidiolex is a plant-derived cannabinoid prescription medicine and the only current FDA-approved form of cannabidiol (CBD). In 2018, the FDA approved the drug to treat people two years of age and older with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.
"We are grateful for the dogged commitment of GW Pharmaceuticals and especially for the TSC clinical trial volunteers, researchers and clinicians who made this possible," said TS Alliance Chief Scientific Officer Steven L. Roberds, PhD. "Epidiolex provides a standardized formulation of CBD with evidence of effectiveness supported by rigorous, well-controlled clinical trials."
Established in 1974, the Tuberous Sclerosis Alliance is an internationally recognized nonprofit organization dedicated to finding a cure for tuberous sclerosis complex while improving the lives of those affected. The organization accomplishes this by developing programs, support services and resource information; stimulating and sponsoring research; and creating and implementing public and professional education programs designed to heighten awareness of the disease. For more information, visit tsalliance.org or email info@tsalliance.org.
Contact:Jaye IshamVP, Communications StrategyTuberous Sclerosis Alliance301.562.9890jisham@tsalliance.org
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SOURCE Tuberous Sclerosis Alliance
馬里蘭州銀泉,2020年7月31日/美通社/--今天,結節性硬化症聯盟(TS聯盟)讚揚美國食品和藥物管理局(FDA)批准Epidiolex®口服溶液治療一歲及以上結節性硬化症(TSC)患者的癲癇發作。TSC在美國影響約5萬人,在全球影響100萬人,是一種遺傳性疾病,可導致重要器官形成非癌症腫瘤;它也是癲癇和自閉症的主要遺傳原因。
“高達85%的受TSC影響的人在一生中的某個時候經歷過癲癇發作,”TS聯盟主席兼首席執行官Kari Luther Rosbeck解釋説。“不幸的是,現有的藥物並不總是能有效地控制它們。我們的組織和TSC社區當然歡迎一種新的選擇,比如Epidiolex,這是FDA批准的第二種針對TSC的藥物。”
由GW製藥公司製造,格林威治生物科學公司在美國分銷的Epidiolex是一種植物來源的大麻類處方藥,也是目前FDA批准的唯一形式的大麻二醇(CBD)。2018年,FDA批准該藥物治療兩歲及以上患有Lennox-Gastaut綜合徵(LGS)或Dravet綜合徵的人。
TS聯盟首席科學官史蒂文·L·羅伯茨博士説:“我們感謝GW製藥公司堅持不懈的承諾,特別是TSC臨牀試驗志願者、研究人員和臨牀醫生,他們使這成為可能。Epidiolex提供了CBD的標準化配方,並有嚴格、控制良好的臨牀試驗支持的有效性證據。“
結節性硬化症聯盟成立於1974年,是一個國際公認的非營利性組織,致力於尋找治療結節性硬化症的方法,同時改善患者的生活。該組織通過開發計劃、支持服務和資源信息、激勵和贊助研究以及創建和實施旨在提高對這種疾病的認識的公共和專業教育計劃來實現這一目標。欲瞭解更多信息,請訪問tsalliance.org或發送電子郵件至info@tsalliance.org。
聯繫人:Communications Strategy Jaye IshamVP電子郵件:Jaye IshamVP@tsalliance.org結節性硬化症聯盟301.562.9890jisham@tsalliance.org
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來源結節性硬化症聯盟