美国食品药品监督管理局授权紧急使用给特朗普治疗新冠肺炎的抗体鸡尾酒

2020-11-25 07:41

FDA authorizes emergency use of the antibody cocktail given to Trump to treat Covid-19 Skh世界播

美国食品药品监督管理局授权紧急使用给特朗普治疗新冠肺炎的抗体鸡尾酒Skh世界播


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Regeneron president: Treatment is given in a targeted fashion Skh世界播

Regeneron主席:治疗是有针对性的Skh世界播


The US Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron's antibody cocktail to treat Covid-19 in high-risk patients with mild to moderate disease. Skh世界播

周六,美国食品和药物管理局(FDA)发布了Regeneron抗体鸡尾酒的紧急使用授权,用于治疗轻中度疾病的高危患者新冠肺炎。Skh世界播


President Donald Trump received the therapy, called REGEN-COV2, when he was hospitalized for coronavirus. The treatment has to be infused into the bloodstream and is meant to mimic an immune response to infection. Skh世界播

唐纳德·特朗普(Donald Trump)总统在因冠状病毒住院时接受了这种名为REGEN-COV2的疗法。这种疗法必须注入血液,以模仿对感染的免疫反应。Skh世界播


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Skh世界播

Skh世界播


The cocktail reduced Covid-19-related hospitalizations and emergency room visits in some patients within 28 days of treatment, the FDA said in a news release. Skh世界播

FDA在一份新闻稿中说,这种鸡尾酒减少了一些患者在治疗后28天内与新冠肺炎相关的住院和急诊室就诊。Skh世界播


Regeneron's chief executive officer, Dr. Leonard S. Schleifer, said in a statement that demand may initially exceed supply, "making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need." Skh世界播

Regeneron的首席执行官伦纳德·S·施莱弗博士(Dr.Leonard S.Schleifer)在一份声明中表示,最初可能会供不应求,“因此,联邦和州政府确保REGEN-COV2病毒公平、公平地分配给最需要帮助的患者变得更加关键。”Skh世界播


An emergency use authorization (EUA) is a lower regulatory bar than full approval by the FDA. An EUA allows products to be used under particular circumstances before all the evidence is available for approval. Skh世界播

与FDA的全面批准相比,紧急使用授权(EUA)的监管门槛更低。EUA允许在所有证据可供批准之前,在特定情况下使用产品。Skh世界播


"When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks," the FDA said. Skh世界播

美国食品药品监督管理局说:“当这些抗体用于治疗授权人群的新冠肺炎时,已知的和潜在的益处超过了已知的和潜在的风险。”Skh世界播


Regeneron submitted its application for the authorization in October, shortly after Trump tested positive for the coronavirus and received the biotechnology company's antibody therapy. Skh世界播

Regeneron在10月份提交了授权申请,不久之前,特朗普的冠状病毒检测呈阳性,并接受了这家生物技术公司的抗体治疗。Skh世界播


"Regeneron now expects to have REGEN-COV2 treatment doses ready for approximately 80,000 patients by the end of November, approximately 200,000 patients by the first week of January, and approximately 300,000 patients in total by the end of January 2021," the company said in a news release Saturday. Skh世界播

该公司在周六的一份新闻稿中表示:“Regeneron现在预计,到11月底,REGEN-COV2治疗剂量将为大约8万名患者准备好,到1月的第一周,大约有20万名患者准备好,到2021年1月底,总共大约有30万名患者。”Skh世界播


Treatment is for use early in infection Skh世界播

治疗是为了在感染早期使用。Skh世界播


Unlike some other drugs used for Covid-19, the antibody cocktail is meant to be given early in infection, before patients are hospitalized or require oxygen therapy. The drug should be given as soon as possible after a positive viral test, according to the FDA. Skh世界播

与新冠肺炎使用的其他一些药物不同,抗体鸡尾酒是在患者住院或需要氧疗之前,在感染早期给予的。根据FDA的说法,这种药物应该在病毒检测呈阳性后尽快服用。Skh世界播


The FDA's authorization is limited to high-risk patients, like those who are older than 65 years of age or have a BMI greater than or equal to 35. Patients with other conditions like diabetes, cardiovascular disease or chronic kidney disease also qualify for the drug. Skh世界播

FDA的授权仅限于高危患者,如65岁以上或BMI大于或等于35的患者。患有糖尿病、心血管疾病或慢性肾脏疾病等其他疾病的患者也有资格服用该药物。Skh世界播


The authorization only applies to patients 12 years of age or older. The cocktail has not been authorized for use in patients who are hospitalized with Covid-19 or need oxygen therapy because of Covid-19. Skh世界播

该授权仅适用于12岁或12岁以上的患者。这种鸡尾酒没有被授权用于与新冠肺炎一起住院或因新冠肺炎而需要氧疗的患者。Skh世界播


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As Trump hails Regeneron treatment, his administration tries to block the science it used Skh世界播

在特朗普欢呼Regeneron治疗的同时,他的政府试图阻止它使用的科学Skh世界播


Regeneron's cocktail is a combination of two monoclonal antibodies, casirivimab and imdevimab, that are produced in a laboratory. Skh世界播

Regeneron的鸡尾酒是由实验室生产的两种单克隆抗体--casirimab和imdemab组合而成的。Skh世界播


The antibodies target the spike protein the virus uses to drill into healthy cells. With two antibodies, the hope is to trap and shut down viral replication. Skh世界播

这些抗体针对的是病毒用来钻入健康细胞的尖峰蛋白。有了这两种抗体,就有希望捕获并阻止病毒复制。Skh世界播


"The FDA remains committed to advancing the nation's public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said FDA Commissioner Dr. Stephen Hahn in a statement. Skh世界播

FDA专员斯蒂芬·哈恩博士在一份声明中说:“在这场史无前例的流行病中,FDA仍然致力于促进国家的公共健康。授权这些单克隆抗体疗法可能有助于避免门诊患者住院,并减轻我们医疗保健系统的负担,”FDA专员斯蒂芬·哈恩(Stephen Hahn)博士在一份声明中说。Skh世界播


Regeneron isn't the only company that's been working on antibody therapies for the coronavirus. There are more than 70 different antibody treatments for Covid-19 under investigation, according to BIO, an association that represents major biotechnology companies Skh世界播

Regeneron并不是唯一一家致力于冠状病毒抗体疗法的公司。根据代表主要生物技术公司的协会BIO的说法,目前有70多种不同的新冠肺炎抗体疗法正在接受调查。Skh世界播


Earlier this month, the FDA issued an emergency use authorization for another antibody treatment from pharmaceutical manufacturer Eli Lilly with similar conditions. Skh世界播

本月早些时候,FDA发布了一项紧急使用授权,允许制药商礼来公司(Eli Lilly)在类似情况下进行另一种抗体治疗。Skh世界播

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