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2021-07-08
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U.S. FDA narrows patient group for Biogen's Alzheimer's drug<blockquote>美国 FDA 缩小百健阿尔茨海默病药物的患者范围</blockquote>
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She expects roughly $12 billion in peak sales by 2031.</p><p><blockquote>Truist Securities 分析师 Robyn Karnauskas 在一份报告中表示，新的患者群体与该药物的预期使用方式基本一致。她预计到 2031 年销售额峰值将达到约 120 亿美元。</blockquote></p><p> Biogen’s drug has been hailed by patient advocates and some neurologists eager for a treatment for the memory-robbing disease. Other doctors said clinical trial results were inconsistent and more proof was needed.</p><p><blockquote>百健公司的药物受到了患者权益倡导者和一些渴望治疗这种剥夺记忆疾病的神经科医生的好评。其他医生表示，临床试验结果不一致，需要更多证据。</blockquote></p><p></p>","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>U.S. FDA narrows patient group for Biogen's Alzheimer's drug<blockquote>美国 FDA 缩小百健阿尔茨海默病药物的患者范围</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; 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}\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\">\nU.S. FDA narrows patient group for Biogen's Alzheimer's drug<blockquote>美国 FDA 缩小百健阿尔茨海默病药物的患者范围</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">Reuters</strong><span class=\"h-time small\">2021-07-08 21:21</span>\n</p>\n</h4>\n</header>\n<article>\n<p>July 8 (Reuters) - Biogen Inc said the U.S. drug regulator has narrowed the patient group that can use its Alzheimer’s disease drug, after the agency drew sharp criticism for approving the drug last month without proof of clear benefit against the disease.</p><p><blockquote>7月8日（路透社）--百健公司（Biogen Inc.）表示，美国药品监管机构已经缩小了可以使用其阿尔茨海默病药物的患者群体范围，此前该机构上个月在没有证据表明该药物对阿尔茨海默病有明显益处的情况下批准了该药物，招致了尖锐批评。</blockquote></p><p> Shares of the company fell nearly 3% before the bell on Thursday.</p><p><blockquote>该公司股价周四盘前下跌近3%。</blockquote></p><p> The U.S. Food and Drug Administration has been criticized for its decision to allow wide use of Biogen’s Aduhelm among patients even though the company had tested the drug only in patients with early disease who tested positive for a component of amyloid brain plaques.</p><p><blockquote>美国美国食品和药物管理局因其允许在患者中广泛使用百健公司的 Aduhelm 的决定而受到批评，尽管该公司只在淀粉样蛋白脑斑块成分检测呈阳性的早期疾病患者身上测试了这种药物。</blockquote></p><p> Aduhelm, also known as aducanumab, was approved despite a lack of clear evidence showing the drug worked and against the advice of an outside group of advisers.</p><p><blockquote>Aduhelm，也称为aducanumab，尽管缺乏明确的证据表明该药物有效，并且违背了外部顾问小组的建议，但还是获得了批准。</blockquote></p><p> Several members of the FDA’s advisory panel have resigned in protest over the approval.</p><p><blockquote>美国食品和药物管理局顾问小组的几名成员已经辞职，以抗议批准。</blockquote></p><p> Biogen said it had asked for an update to the label, a written information that accompanies a drug, after “dialogue with FDA, physicians and patient advocates.” “The intent is to help prescribing physicians to engage with patients,” Biogen said in a statement.</p><p><blockquote>百健公司表示，在 “与美国食品和药物管理局、医生和患者权益倡导者对话 ”后，它已要求更新药品标签（药品随附的书面信息）。“百健在一份声明中说：”我们的目的是帮助开处方的医生与病人互动。</blockquote></p><p> The new label says that treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease.</p><p><blockquote>新标签称，该药物的治疗应在轻度认知障碍或轻度痴呆阶段的患者中开始。</blockquote></p><p> It also says there is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.</p><p><blockquote>它还表示，没有关于在疾病早期或晚期开始治疗的安全性或有效性数据。</blockquote></p><p> The new patient population is largely in-line with how the drug was expected to be used, Truist Securities analyst Robyn Karnauskas said in a note. She expects roughly $12 billion in peak sales by 2031.</p><p><blockquote>Truist Securities 分析师 Robyn Karnauskas 在一份报告中表示，新的患者群体与该药物的预期使用方式基本一致。她预计到 2031 年销售额峰值将达到约 120 亿美元。</blockquote></p><p> Biogen’s drug has been hailed by patient advocates and some neurologists eager for a treatment for the memory-robbing disease. Other doctors said clinical trial results were inconsistent and more proof was needed.</p><p><blockquote>百健公司的药物受到了患者权益倡导者和一些渴望治疗这种剥夺记忆疾病的神经科医生的好评。其他医生表示，临床试验结果不一致，需要更多证据。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源：<a href=\"https://www.reuters.com/article/biogen-alzheimers-fda/update-2-u-s-fda-narrows-patient-group-for-biogens-alzheimers-drug-idUSL3N2OK2XT\">Reuters</a></p>\n<p>为提升您的阅读体验，我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"BIIB":"渤健公司"},"source_url":"https://www.reuters.com/article/biogen-alzheimers-fda/update-2-u-s-fda-narrows-patient-group-for-biogens-alzheimers-drug-idUSL3N2OK2XT","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1184325113","content_text":"July 8 (Reuters) - Biogen Inc said the U.S. drug regulator has narrowed the patient group that can use its Alzheimer’s disease drug, after the agency drew sharp criticism for approving the drug last month without proof of clear benefit against the disease.\nShares of the company fell nearly 3% before the bell on Thursday.\nThe U.S. Food and Drug Administration has been criticized for its decision to allow wide use of Biogen’s Aduhelm among patients even though the company had tested the drug only in patients with early disease who tested positive for a component of amyloid brain plaques.\nAduhelm, also known as aducanumab, was approved despite a lack of clear evidence showing the drug worked and against the advice of an outside group of advisers.\nSeveral members of the FDA’s advisory panel have resigned in protest over the approval.\nBiogen said it had asked for an update to the label, a written information that accompanies a drug, after “dialogue with FDA, physicians and patient advocates.” “The intent is to help prescribing physicians to engage with patients,” Biogen said in a statement.\nThe new label says that treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease.\nIt also says there is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.\nThe new patient population is largely in-line with how the drug was expected to be used, Truist Securities analyst Robyn Karnauskas said in a note. She expects roughly $12 billion in peak sales by 2031.\nBiogen’s drug has been hailed by patient advocates and some neurologists eager for a treatment for the memory-robbing disease. Other doctors said clinical trial results were inconsistent and more proof was needed.","news_type":1,"symbols_score_info":{"BIIB":0.9}},"isVote":1,"tweetType":1,"viewCount":632,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"EN","currentLanguage":"EN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":12,"xxTargetLangEnum":"ORIG"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/143030568"}
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