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2021-12-09

AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease<blockquote>阿斯利康 Covid-19 抗体获 FDA 授权作为预防症状性疾病的新工具</blockquote>

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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":602847732,"tweetId":"602847732","gmtCreate":1639010147327,"gmtModify":1639010147455,"author":{"id":4090202748844200,"idStr":"4090202748844200","authorId":4090202748844200,"authorIdStr":"4090202748844200","name":"BotakTur","avatar":"https://static.tigerbbs.com/fbfb7690052b45745da7270aa672c42d","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":11,"crmLevelSwitch":0,"individualDisplayBadges":[],"wearingBadges":[],"fanSize":12,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"title":"","extraTitle":"","html":"<html><head></head><body>Ok</body></html>","htmlText":"<html><head></head><body>Ok</body></html>","text":"Ok","highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":2,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/602847732","repostId":1141494008,"repostType":4,"repost":{"id":"1141494008","kind":"news","pubTimestamp":1639009033,"share":"https://www.laohunote.com/m/news/1141494008?lang=zh_CN&edition=full","pubTime":"2021-12-09 08:17","market":"us","language":"en","title":"AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease<blockquote>阿斯利康 Covid-19 抗体获 FDA 授权作为预防症状性疾病的新工具</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1141494008","media":"The Wall Street Journal","summary":"The U.S. Food and Drug Administration authorized a preventive antibody combination from AstraZeneca ","content":" The U.S. Food and Drug Administration authorized a preventive antibody combination from AstraZeneca AZN 0.68% PLC that has shown strong efficacy in reducing risk of symptomatic Covid-19, offering a first-of-its-kind alternative for a minority of people for whom vaccines are considered less effective.<blockquote>美国美国食品和药物管理局批准了阿斯利康 AZN 0.68% PLC 的一种预防性抗体组合，该组合在降低有症状的 Covid-19 风险方面显示出强大的功效，为少数疫苗被认为不太有效的人提供了一种首创的替代品。</blockquote> The antibody cocktail, called Evusheld, is aimed primarily for use in a minority of adolescents and adults age 12 and older with moderate to severely compromised immune systems. That may be because they have cancer or another illness or take medications or undergo treatments such as chemotherapy that inhibit an immune response to Covid-19 vaccines, the FDA said in a statement.<blockquote>这种名为Evusheld的抗体鸡尾酒主要用于少数免疫系统中度至重度受损的12岁及以上青少年和成年人。FDA 在一份声明中表示，这可能是因为他们患有癌症或其他疾病，或者正在服用药物或接受化疗等治疗，这些治疗会抑制对 Covid-19 疫苗的免疫反应。</blockquote> AstraZeneca said earlier this year that it would aim the antibody combination, called AZD7442 and delivered as two consecutive shots, at preventing Covid-19 symptoms, like a vaccine. Emergency-use authorization from the FDA offers a new preventive option in addition to widely deployed vaccines.<blockquote>阿斯利康今年早些时候表示，它将把这种名为 AZD7442 的抗体组合用于预防 Covid-19 症状，就像疫苗一样。除了广泛部署的疫苗之外，FDA的紧急使用授权提供了一种新的预防选择。</blockquote> AstraZeneca said about seven million people in the U.S. may benefit from Evusheld to reduce their risk of symptomatic Covid-19 if taken before exposure.<blockquote>阿斯利康表示，如果在接触前服用，美国约有 700 万人可能会受益于 Evusheld，以降低出现症状 Covid-19 的风险。</blockquote> Monoclonal antibodies are the only drug treatments authorized for mild to moderate Covid-19 cases in people who aren’t sick enough to be hospitalized. The drugs, which are given by infusion or injection, provide a temporary substitute for the antibodies produced by the immune system to fight the virus after infection or vaccination.<blockquote>单克隆抗体是唯一获准用于轻度至中度 Covid-19 病例的药物治疗方法，这些病例的病情尚未严重到需要住院治疗的程度。这些药物通过输注或注射给药，为感染或接种疫苗后免疫系统产生的抗体提供了临时替代品，以对抗病毒。</blockquote> AstraZeneca’s drug is the first to get U.S. clearance to prevent Covid-19 in people who aren’t yet infected, but the company could face competition in the coming months. Rivals including Regeneron Pharmaceuticals Inc. are also seeking authorization for drugs to temporarily defend against infection.<blockquote>阿斯利康的药物是第一个获得美国批准的药物，可在尚未感染 Covid-19 的人群中预防 Covid-19，但该公司在未来几个月可能会面临竞争。包括再生元制药公司在内的竞争对手也在寻求药物授权，以暂时抵御感染。</blockquote> Regeneron said in November that its antibody drug REGEN-COV was 82% effective at preventing infection at least eight months after infusion in a study that included patients who hadn’t yet been exposed to the virus. Pfizer Inc. is also testing its antiviral pill Paxlovid to prevent infections in people recently exposed to the virus, which could provide another option for people with weakened immune systems.<blockquote>Regeneron 在 11 月表示，其抗体药物 REGEN-COV 在一项包括尚未接触过病毒的患者在内的研究中，在输注后至少八个月内预防感染的有效率为 82%。辉瑞公司也在测试其抗病毒药丸Paxlovid，以防止最近接触过该病毒的人感染，这可能为免疫系统较弱的人提供另一种选择。</blockquote> The FDA said the authorization is for individuals not infected or recently exposed to someone infected with the virus. It said that vaccines remain “the best defense available against Covid-19.” In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that Evusheld could help reduce the risk of Covid-19 in a subset of the population with a history of adverse reactions to Covid-19 vaccines or their components or with compromised immune systems.<blockquote>美国食品和药物管理局表示，该授权适用于未感染或最近接触过感染该病毒的人的个人。报告称，疫苗仍然是 “抵御 Covid-19 的最佳防御手段”。美国食品和药物管理局药物评估与研究中心主任帕特里齐亚-卡瓦佐尼（Patrizia Cavazzoni）在该机构的声明中说，Evusheld 可以帮助降低对 Covid-19 疫苗或其成分有不良反应史或免疫系统受损的一部分人群感染 Covid-19 的风险。</blockquote> “Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended,” the FDA said.<blockquote>“美国食品和药物管理局说：”对于建议接种 Covid-19 疫苗的个体，使用 Evusheld 进行暴露前预防不能替代疫苗接种。</blockquote> The antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford. That vaccine is one of the most broadly distributed globally, with more than 2.2 billion doses delivered, but it isn’t authorized for use in the U.S.<blockquote>这种抗体疗法与阿斯利康与牛津大学合作开发的广泛使用的 Covid-19 疫苗是分开的。这种疫苗是全球分发最广泛的疫苗之一，已交付超过 22 亿剂，但未被授权在美国使用。</blockquote> AstraZeneca said it’s testing Evusheld against the new Omicron variant. It “neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” said Mene Pangalos, the company’s executive vice president for biopharmaceuticals research and development, in a statement.<blockquote>阿斯利康表示，它正在对 Evusheld 进行针对奥密克戎新变种的测试。该公司负责生物制药研发的执行副总裁梅内-潘加洛斯（Mene Pangalos）在一份声明中说：“它 “中和了迄今为止所有以前的 SARS-CoV-2 变种，我们正在迅速确定其对新的奥密克戎变种的疗效”。</blockquote> Some scientists think that Omicron may have developed in a patient whose immune response was too weak to clear the virus, allowing it time to adapt and mutate. The rise of variants like Omicron highlights the need for treatments to better protect people who mount weak immune responses to the virus causing Covid-19, scientists say.<blockquote>一些科学家认为，奥密克戎病毒可能是在一名免疫反应太弱而无法清除病毒的患者身上发展起来的，这给了它时间适应和变异。科学家说，奥密克戎等变种的兴起凸显了治疗的必要性，以更好地保护那些对导致新冠肺炎的病毒免疫反应较弱的人。</blockquote> The company in August said Evusheld, also called AZD7442, showed 77% efficacy in reducing risk of symptomatic Covid-19 compared with a placebo in late-stage clinical trials testing its usefulness as a preventive treatment. In summarized preliminary findings, the company said that more than three-fourths of the 5,197 participants in the trial had comorbidities, or chronic disease, including conditions that could render vaccines less effective.<blockquote>该公司在 8 月份表示，Evusheld（也称为 AZD7442）在测试其作为预防性治疗的有效性的后期临床试验中，与安慰剂相比，在降低有症状的 Covid-19 风险方面显示出 77% 的功效。该公司在总结初步调查结果时表示，该试验的 5,197 名参与者中，超过四分之三患有合并症或慢性疾病，包括可能降低疫苗有效性的疾病。</blockquote> Protection has been shown to last six months, the FDA and AstraZeneca said. Evaluation of the antibody combination is ongoing.<blockquote>FDA 和阿斯利康表示，保护作用已被证明可持续六个月。抗体组合的评价正在进行中。</blockquote> Monoclonal antibody drugs are designed to mimic natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca earlier hoped the therapy could be used to treat acute Covid-19 symptoms and stem infection to keep people already exposed to the virus out of the hospital. But the drug failed in late-stage trials for that primary purpose.<blockquote>单克隆抗体药物旨在模拟免疫系统产生的天然抗体，以对抗冠状病毒。阿斯利康早些时候希望该疗法可用于治疗急性 Covid-19 症状并阻止感染，以使已经接触过病毒的人远离医院。但该药物在主要目的的后期试验中失败了。</blockquote> Earlier in the pandemic, AstraZeneca received funding pledges that could exceed $700 million from the U.S. government to develop, test and potentially supply up to 700,000 doses of AZD7442 this year. The antibodies used were developed by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.<blockquote>在疫情早些时候，阿斯利康从美国政府获得了超过 7 亿美元的资金承诺，用于今年开发、测试并可能供应多达 70 万剂 AZD7442。使用的抗体由范德比尔特大学医学中心开发，并于2020年6月授权给阿斯利康。</blockquote> European medicines regulators are also reviewing data for potential authorization of the antibody combination.<blockquote>欧洲药品监管机构也在审查抗体组合潜在授权的数据。</blockquote>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease<blockquote>阿斯利康 Covid-19 抗体获 FDA 授权作为预防症状性疾病的新工具</blockquote></title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nAstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease<blockquote>阿斯利康 Covid-19 抗体获 FDA 授权作为预防症状性疾病的新工具</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nThe Wall Street Journal2021-12-09 08:17\n\n</h4>\n</header>\n<article>\n The U.S. Food and Drug Administration authorized a preventive antibody combination from AstraZeneca AZN 0.68% PLC that has shown strong efficacy in reducing risk of symptomatic Covid-19, offering a first-of-its-kind alternative for a minority of people for whom vaccines are considered less effective.<blockquote>美国美国食品和药物管理局批准了阿斯利康 AZN 0.68% PLC 的一种预防性抗体组合，该组合在降低有症状的 Covid-19 风险方面显示出强大的功效，为少数疫苗被认为不太有效的人提供了一种首创的替代品。</blockquote> The antibody cocktail, called Evusheld, is aimed primarily for use in a minority of adolescents and adults age 12 and older with moderate to severely compromised immune systems. That may be because they have cancer or another illness or take medications or undergo treatments such as chemotherapy that inhibit an immune response to Covid-19 vaccines, the FDA said in a statement.<blockquote>这种名为Evusheld的抗体鸡尾酒主要用于少数免疫系统中度至重度受损的12岁及以上青少年和成年人。FDA 在一份声明中表示，这可能是因为他们患有癌症或其他疾病，或者正在服用药物或接受化疗等治疗，这些治疗会抑制对 Covid-19 疫苗的免疫反应。</blockquote> AstraZeneca said earlier this year that it would aim the antibody combination, called AZD7442 and delivered as two consecutive shots, at preventing Covid-19 symptoms, like a vaccine. Emergency-use authorization from the FDA offers a new preventive option in addition to widely deployed vaccines.<blockquote>阿斯利康今年早些时候表示，它将把这种名为 AZD7442 的抗体组合用于预防 Covid-19 症状，就像疫苗一样。除了广泛部署的疫苗之外，FDA的紧急使用授权提供了一种新的预防选择。</blockquote> AstraZeneca said about seven million people in the U.S. may benefit from Evusheld to reduce their risk of symptomatic Covid-19 if taken before exposure.<blockquote>阿斯利康表示，如果在接触前服用，美国约有 700 万人可能会受益于 Evusheld，以降低出现症状 Covid-19 的风险。</blockquote> Monoclonal antibodies are the only drug treatments authorized for mild to moderate Covid-19 cases in people who aren’t sick enough to be hospitalized. The drugs, which are given by infusion or injection, provide a temporary substitute for the antibodies produced by the immune system to fight the virus after infection or vaccination.<blockquote>单克隆抗体是唯一获准用于轻度至中度 Covid-19 病例的药物治疗方法，这些病例的病情尚未严重到需要住院治疗的程度。这些药物通过输注或注射给药，为感染或接种疫苗后免疫系统产生的抗体提供了临时替代品，以对抗病毒。</blockquote> AstraZeneca’s drug is the first to get U.S. clearance to prevent Covid-19 in people who aren’t yet infected, but the company could face competition in the coming months. Rivals including Regeneron Pharmaceuticals Inc. are also seeking authorization for drugs to temporarily defend against infection.<blockquote>阿斯利康的药物是第一个获得美国批准的药物，可在尚未感染 Covid-19 的人群中预防 Covid-19，但该公司在未来几个月可能会面临竞争。包括再生元制药公司在内的竞争对手也在寻求药物授权，以暂时抵御感染。</blockquote> Regeneron said in November that its antibody drug REGEN-COV was 82% effective at preventing infection at least eight months after infusion in a study that included patients who hadn’t yet been exposed to the virus. Pfizer Inc. is also testing its antiviral pill Paxlovid to prevent infections in people recently exposed to the virus, which could provide another option for people with weakened immune systems.<blockquote>Regeneron 在 11 月表示，其抗体药物 REGEN-COV 在一项包括尚未接触过病毒的患者在内的研究中，在输注后至少八个月内预防感染的有效率为 82%。辉瑞公司也在测试其抗病毒药丸Paxlovid，以防止最近接触过该病毒的人感染，这可能为免疫系统较弱的人提供另一种选择。</blockquote> The FDA said the authorization is for individuals not infected or recently exposed to someone infected with the virus. It said that vaccines remain “the best defense available against Covid-19.” In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that Evusheld could help reduce the risk of Covid-19 in a subset of the population with a history of adverse reactions to Covid-19 vaccines or their components or with compromised immune systems.<blockquote>美国食品和药物管理局表示，该授权适用于未感染或最近接触过感染该病毒的人的个人。报告称，疫苗仍然是 “抵御 Covid-19 的最佳防御手段”。美国食品和药物管理局药物评估与研究中心主任帕特里齐亚-卡瓦佐尼（Patrizia Cavazzoni）在该机构的声明中说，Evusheld 可以帮助降低对 Covid-19 疫苗或其成分有不良反应史或免疫系统受损的一部分人群感染 Covid-19 的风险。</blockquote> “Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended,” the FDA said.<blockquote>“美国食品和药物管理局说：”对于建议接种 Covid-19 疫苗的个体，使用 Evusheld 进行暴露前预防不能替代疫苗接种。</blockquote> The antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford. That vaccine is one of the most broadly distributed globally, with more than 2.2 billion doses delivered, but it isn’t authorized for use in the U.S.<blockquote>这种抗体疗法与阿斯利康与牛津大学合作开发的广泛使用的 Covid-19 疫苗是分开的。这种疫苗是全球分发最广泛的疫苗之一，已交付超过 22 亿剂，但未被授权在美国使用。</blockquote> AstraZeneca said it’s testing Evusheld against the new Omicron variant. It “neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” said Mene Pangalos, the company’s executive vice president for biopharmaceuticals research and development, in a statement.<blockquote>阿斯利康表示，它正在对 Evusheld 进行针对奥密克戎新变种的测试。该公司负责生物制药研发的执行副总裁梅内-潘加洛斯（Mene Pangalos）在一份声明中说：“它 “中和了迄今为止所有以前的 SARS-CoV-2 变种，我们正在迅速确定其对新的奥密克戎变种的疗效”。</blockquote> Some scientists think that Omicron may have developed in a patient whose immune response was too weak to clear the virus, allowing it time to adapt and mutate. The rise of variants like Omicron highlights the need for treatments to better protect people who mount weak immune responses to the virus causing Covid-19, scientists say.<blockquote>一些科学家认为，奥密克戎病毒可能是在一名免疫反应太弱而无法清除病毒的患者身上发展起来的，这给了它时间适应和变异。科学家说，奥密克戎等变种的兴起凸显了治疗的必要性，以更好地保护那些对导致新冠肺炎的病毒免疫反应较弱的人。</blockquote> The company in August said Evusheld, also called AZD7442, showed 77% efficacy in reducing risk of symptomatic Covid-19 compared with a placebo in late-stage clinical trials testing its usefulness as a preventive treatment. In summarized preliminary findings, the company said that more than three-fourths of the 5,197 participants in the trial had comorbidities, or chronic disease, including conditions that could render vaccines less effective.<blockquote>该公司在 8 月份表示，Evusheld（也称为 AZD7442）在测试其作为预防性治疗的有效性的后期临床试验中，与安慰剂相比，在降低有症状的 Covid-19 风险方面显示出 77% 的功效。该公司在总结初步调查结果时表示，该试验的 5,197 名参与者中，超过四分之三患有合并症或慢性疾病，包括可能降低疫苗有效性的疾病。</blockquote> Protection has been shown to last six months, the FDA and AstraZeneca said. Evaluation of the antibody combination is ongoing.<blockquote>FDA 和阿斯利康表示，保护作用已被证明可持续六个月。抗体组合的评价正在进行中。</blockquote> Monoclonal antibody drugs are designed to mimic natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca earlier hoped the therapy could be used to treat acute Covid-19 symptoms and stem infection to keep people already exposed to the virus out of the hospital. But the drug failed in late-stage trials for that primary purpose.<blockquote>单克隆抗体药物旨在模拟免疫系统产生的天然抗体，以对抗冠状病毒。阿斯利康早些时候希望该疗法可用于治疗急性 Covid-19 症状并阻止感染，以使已经接触过病毒的人远离医院。但该药物在主要目的的后期试验中失败了。</blockquote> Earlier in the pandemic, AstraZeneca received funding pledges that could exceed $700 million from the U.S. government to develop, test and potentially supply up to 700,000 doses of AZD7442 this year. The antibodies used were developed by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.<blockquote>在疫情早些时候，阿斯利康从美国政府获得了超过 7 亿美元的资金承诺，用于今年开发、测试并可能供应多达 70 万剂 AZD7442。使用的抗体由范德比尔特大学医学中心开发，并于2020年6月授权给阿斯利康。</blockquote> European medicines regulators are also reviewing data for potential authorization of the antibody combination.<blockquote>欧洲药品监管机构也在审查抗体组合潜在授权的数据。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://www.wsj.com/articles/astrazeneca-covid-19-antibody-authorized-by-fda-as-novel-tool-to-prevent-symptomatic-disease-11639005991?mod=hp_lista_pos4\">The Wall Street Journal</a>\n为提升您的阅读体验，我们对本页面进行了排版优化\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"AZN":"阿斯利康"},"source_url":"https://www.wsj.com/articles/astrazeneca-covid-19-antibody-authorized-by-fda-as-novel-tool-to-prevent-symptomatic-disease-11639005991?mod=hp_lista_pos4","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1141494008","content_text":"The U.S. Food and Drug Administration authorized a preventive antibody combination from AstraZeneca AZN 0.68% PLC that has shown strong efficacy in reducing risk of symptomatic Covid-19, offering a first-of-its-kind alternative for a minority of people for whom vaccines are considered less effective.\n\nThe antibody cocktail, called Evusheld, is aimed primarily for use in a minority of adolescents and adults age 12 and older with moderate to severely compromised immune systems. That may be because they have cancer or another illness or take medications or undergo treatments such as chemotherapy that inhibit an immune response to Covid-19 vaccines, the FDA said in a statement.\n\nAstraZeneca said earlier this year that it would aim the antibody combination, called AZD7442 and delivered as two consecutive shots, at preventing Covid-19 symptoms, like a vaccine. Emergency-use authorization from the FDA offers a new preventive option in addition to widely deployed vaccines.\n\nAstraZeneca said about seven million people in the U.S. may benefit from Evusheld to reduce their risk of symptomatic Covid-19 if taken before exposure.\n\nMonoclonal antibodies are the only drug treatments authorized for mild to moderate Covid-19 cases in people who aren’t sick enough to be hospitalized. The drugs, which are given by infusion or injection, provide a temporary substitute for the antibodies produced by the immune system to fight the virus after infection or vaccination.\n\nAstraZeneca’s drug is the first to get U.S. clearance to prevent Covid-19 in people who aren’t yet infected, but the company could face competition in the coming months. Rivals including Regeneron Pharmaceuticals Inc. are also seeking authorization for drugs to temporarily defend against infection.\n\nRegeneron said in November that its antibody drug REGEN-COV was 82% effective at preventing infection at least eight months after infusion in a study that included patients who hadn’t yet been exposed to the virus. Pfizer Inc. is also testing its antiviral pill Paxlovid to prevent infections in people recently exposed to the virus, which could provide another option for people with weakened immune systems.\n\n\nThe FDA said the authorization is for individuals not infected or recently exposed to someone infected with the virus. It said that vaccines remain “the best defense available against Covid-19.” In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that Evusheld could help reduce the risk of Covid-19 in a subset of the population with a history of adverse reactions to Covid-19 vaccines or their components or with compromised immune systems.\n\n“Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended,” the FDA said.\n\nThe antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford. That vaccine is one of the most broadly distributed globally, with more than 2.2 billion doses delivered, but it isn’t authorized for use in the U.S.\n\nAstraZeneca said it’s testing Evusheld against the new Omicron variant. It “neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” said Mene Pangalos, the company’s executive vice president for biopharmaceuticals research and development, in a statement.\n\nSome scientists think that Omicron may have developed in a patient whose immune response was too weak to clear the virus, allowing it time to adapt and mutate. The rise of variants like Omicron highlights the need for treatments to better protect people who mount weak immune responses to the virus causing Covid-19, scientists say.\n\nThe company in August said Evusheld, also called AZD7442, showed 77% efficacy in reducing risk of symptomatic Covid-19 compared with a placebo in late-stage clinical trials testing its usefulness as a preventive treatment. In summarized preliminary findings, the company said that more than three-fourths of the 5,197 participants in the trial had comorbidities, or chronic disease, including conditions that could render vaccines less effective.\n\nProtection has been shown to last six months, the FDA and AstraZeneca said. Evaluation of the antibody combination is ongoing.\n\nMonoclonal antibody drugs are designed to mimic natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca earlier hoped the therapy could be used to treat acute Covid-19 symptoms and stem infection to keep people already exposed to the virus out of the hospital. But the drug failed in late-stage trials for that primary purpose.\n\n\nEarlier in the pandemic, AstraZeneca received funding pledges that could exceed $700 million from the U.S. government to develop, test and potentially supply up to 700,000 doses of AZD7442 this year. The antibodies used were developed by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.\n\nEuropean medicines regulators are also reviewing data for potential authorization of the antibody combination.","news_type":1,"symbols_score_info":{"AZN":0.9}},"isVote":1,"tweetType":1,"viewCount":1066,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":2,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/602847732"}