吉利德首席医学官医学博士梅达德·帕赛发表声明。

2020年1月31日 , 加利福尼亚州的福斯特城 , 吉利德科学公司(Gilead Sciences , 以下简称:吉利德)首席医学官医学博士梅达德·帕赛(Merdad Parsey)发表以下声明 。 声明全文“吉利德(见注释)正在与全球卫生当局密切合作 , 通过适当地、实验性使用我们的研究化合物瑞德西韦(Remdesivir)药物来应对新型冠状病毒(2019-nCoV)的爆发 。 与美国食品药品监督管理局(FDA)、美国疾病控制中心(CDC)、美国卫生与公共服务部(DHHS)、中国疾病预防控制中心和国家药品监督管理局(NMPA) , 美国国家过敏与传染病研究所(NIAID) , 以及个体研究人员和临床医生等一起合作 , 吉利德专注于提供抗病毒专业知识和资源 , 以帮助病人和社区抗击新型冠状病毒 。 瑞德西韦药物尚未在全球任何地方获得许可或批准 , 并且尚未证明对任何用途都是安全或有效的 。 应主治医师的要求 , 并在当地监管机构的支持下(权衡了在新型冠状病毒中提供无数据的实验药物的风险和收益) , 吉利德在没有任何批准的治疗方案的情况下 , 提供了瑞德西韦药物用于少数新型冠状病毒患者 , 用于紧急治疗 。 吉利德正在与中国卫生部门合作建立一项随机对照试验 , 以确定瑞德西韦药物是否可以安全有效地用于治疗新型冠状病毒患者 。 我们还将加快针对新型冠状病毒样品的瑞德西韦药物的适当实验室测试 。 尽管目前尚无瑞德西韦药物的抗病毒数据 , 但其他冠状病毒的可用数据给了我们希望 。 瑞德西韦药物在动物模型中已证明其对病毒病原体MERS和SARS的体外和体内活性 , 这是与新型冠状病毒结构相似的冠状病毒 。 紧急使用瑞德西韦药物治疗埃博拉病毒感染患者的可用临床数据也有限 。 吉利德致力于支持全球卫生界 , 以迅速 , 有效地应对全球范围内严重且威胁生命的病毒爆发 。 ”英文声明(全文)Gilead Sciences Statement on the Company’s Ongoing Response to the 2019 Novel Coronavirus (2019-nCoV)Foster City, Calif., January 31, 2020 — Gilead Sciences today issued the following statement from Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences:"Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir. Together with the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (DHHS), the China CDC and National Medical Product Administration (NMPA), the World Health Organization (WHO), and the U.S. National Institute of Allergies and Infectious Diseases (NIAID), and along with individual researchers and clinicians, Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting 2019-nCoV.Remdesivir is not yet licensed or approved anywhere globally and has not been demonstrated to be safe or effective for any use. At the request of treating physicians, and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options.Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.While there are no antiviral data for remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope. Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV. There are also limited clinical data available from the emergency use of remdesivir in the treatment of patients with Ebola virus infection.Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide."


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