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2021-06-08

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Controversial Biogen Alzheimer Drug Wins FDA Approval<blockquote>备受争议的百健阿尔茨海默病药物获得 FDA 批准</blockquote>

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{"i18n":{"language":"zh_CN"},"detailType":1,"isChannel":false,"data":{"magic":2,"id":114481303,"tweetId":"114481303","gmtCreate":1623087740802,"gmtModify":1631889244259,"author":{"id":3579418112520180,"idStr":"3579418112520180","authorId":3579418112520180,"authorIdStr":"3579418112520180","name":"LIHUI","avatar":"https://static.tigerbbs.com/74e419c79093348e7ec1d10e5b39e08e","vip":1,"userType":1,"introduction":"","boolIsFan":false,"boolIsHead":false,"crmLevel":11,"crmLevelSwitch":0,"individualDisplayBadges":[],"wearingBadges":[],"fanSize":4,"starInvestorFlag":false},"themes":[],"images":[],"coverImages":[],"title":"","extraTitle":"","html":"<html><head></head><body>Like please</body></html>","htmlText":"<html><head></head><body>Like please</body></html>","text":"Like please","highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":1,"repostSize":0,"favoriteSize":0,"link":"https://laohu8.com/post/114481303","repostId":1133110564,"repostType":4,"repost":{"id":"1133110564","kind":"news","pubTimestamp":1623080895,"share":"https://www.laohunote.com/m/news/1133110564?lang=zh_CN&edition=full","pubTime":"2021-06-07 23:48","market":"us","language":"en","title":"Controversial Biogen Alzheimer Drug Wins FDA Approval<blockquote>备受争议的百健阿尔茨海默病药物获得 FDA 批准</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1133110564","media":"zerohedge","summary":"In what could be a major coup for Biogen, the FDA on Monday approved Aduhelm (aducanumab), Biogen's ","content":"In what could be a major coup for Biogen, the FDA on Monday approved Aduhelm (aducanumab), Biogen's experimental drug for treating the physiological causes of Alzheimer's, as the first treatment to address an underlying cause of the disease despite the remaining controversy over the drug's decidedly mixed clinical trial results.<blockquote>FDA 周一批准了 Biogen 用于治疗阿尔茨海默病生理原因的实验性药物 Aduhelm (aducanumab)，这可能是对百健 (Biogen) 来说的一个重大政变，尽管该药物的临床试验结果明显好坏参半，但仍有争议。</blockquote> AsReutersexplains, Aduhelm is one of a long list of drugs that have aimed to remove sticky deposits of a protein called amyloid beta from the brains of patients suffering from early-stage Alzheimer's in order to stave off the worst ravages of the disease, which is characterized by severe memory loss and the loss of the ability to care for oneself.<blockquote>正如路透社解释的那样，Aduhelm 是一长串旨在清除早期阿尔茨海默氏症患者大脑中一种称为淀粉样蛋白 β 的蛋白质粘性沉积物的药物之一，以避免该疾病最严重的破坏，其特征是严重的记忆力丧失和丧失自理能力。</blockquote> The clinical trials for Aduhelm were the first to show that a reduction in these plaques (which are considered a hallmark symptom of the disease) can slow the clinical decline of a patient.<blockquote>Aduhelm的临床试验首次表明，这些斑块（被认为是该疾病的标志性症状）的减少可以减缓患者的临床下降。</blockquote> The drug has created a rift in the professional community that was mentioned inthe FDA's press release: the agency said that the data included in the Biogen's submission - which were derived from two phase 3 clinical trials - were \"highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.\" Many scientists opposed the drug's approval, saying it doesn't work.<blockquote>该药物在专业界造成了裂痕，FDA 的新闻稿中提到了这一点：该机构表示，百健提交的材料中包含的数据（来自两项 3 期临床试验）“非常复杂，在临床益处方面留下了剩余的不确定性。关于 Aduhelm 是否应该获得批准，公众一直存在相当大的争论。正如在解释科学数据时经常发生的那样，专家界提出了不同的观点”。许多科学家反对该药物的批准，称其不起作用。</blockquote> As a result, Biogen will be required to conduct another round of post-approval clinical studies (what the FDA is calling a \"Phase 4\" trial).<blockquote>因此，百健将被要求进行另一轮批准后的临床研究（FDA称之为“4期”试验）。</blockquote> Biogen's new drug is the first Alzheimer's treatment approved since 2003. Existing treatment courses for the disease don't do much to arrest the underlying causes, but rather are designed to make patients more comfortable.<blockquote>百健的新药是自2003年以来第一个被批准的阿尔茨海默病治疗药物。该疾病的现有治疗方案并没有起到多大作用来阻止潜在的原因，而是旨在让患者更舒适。</blockquote> FDA approved Aduhelm to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, which allowed for the drug's approval thanks to the success it showed in reducing the amyloid beta brain plaque.<blockquote>美国食品和药物管理局批准 Aduhelm 使用加速批准途径治疗阿尔茨海默病患者，由于该药物在减少β淀粉样蛋白脑斑块方面取得了成功，因此获得了批准。</blockquote> Shares of Biogen climbed on the news, as did shares in other companies known to be working on alzheimer treatments, including Biogen rival Eli Lilly. The Nasdaq biotech index climbed to a session high.<blockquote>这一消息传出后，百健的股价上涨，其他已知从事阿尔茨海默氏症治疗的公司的股价也随之上涨，其中包括百健的竞争对手礼来公司。纳斯达克生物技术指数攀升至盘中高点。</blockquote> <img src=\"https://static.tigerbbs.com/ac26030030981a2daa2396729b972e22\" tg-width=\"500\" tg-height=\"337\">Read the full press release below:<blockquote>阅读下面的完整新闻稿：</blockquote> Today FDA approved&nbsp;Aduhelm (aducanumab)&nbsp;to treat patients with Alzheimer’s disease using the&nbsp;Accelerated Approval&nbsp;pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.<blockquote>今天，美国食品和药物管理局批准了 Aduhelm（aducanumab），使用加速批准途径治疗阿尔茨海默病患者，根据该途径，美国食品和药物管理局批准了一种治疗严重或危及生命疾病的药物，如果该药物被证明对替代终点产生影响，且该药物的临床益处仍存在一些不确定性，则该药物可能比现有治疗提供有意义的治疗益处。</blockquote> This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.&nbsp; The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.<blockquote>这一批准在很多方面都意义重大。Aduhelm 是自 2003 年以来获批治疗阿尔茨海默病的第一种新疗法。也许更重要的是，Aduhelm 是第一个针对阿尔茨海默病潜在病理生理学--大脑中存在 β 淀粉样蛋白斑块--的治疗方法。Aduhelm 的临床试验首次表明，这些斑块的减少--这是阿尔茨海默病患者大脑中的一个标志性发现--有望减少这种毁灭性痴呆症的临床下降。</blockquote> We are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.<blockquote>我们很清楚围绕这一批准的关注。我们了解到，Aduhelm 已经引起了媒体、阿尔茨海默氏症患者社区、我们的民选官员和其他相关利益相关者的关注。在对一种严重的、危及生命的疾病进行治疗的情况下，这么多人关注这篇综述的结果是有道理的。此外，申请人提交的材料中包含的数据非常复杂，在临床获益方面留下了剩余的不确定性。关于是否应该批准Aduhelm，公众进行了相当多的辩论。正如在解释科学数据时经常发生的那样，专家群体提供了不同的观点。</blockquote> At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. We examined the clinical trial findings with a fine-tooth comb, we solicited input from the&nbsp;Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.<blockquote>归根结底，在数据不明确的情况下做出监管决策时，我们遵循了通常的行动方针。我们用细齿梳子检查了临床试验结果，我们征求了外周和中枢神经系统药物咨询委员会的意见，我们听取了患者群体的观点，我们审查了所有相关数据。我们最终决定使用加速审批途径——该途径旨在为严重疾病患者提供更早获得潜在有价值的疗法的途径，这些患者的需求未得到满足，并且尽管存在一些关于该益处的剩余不确定性，但仍有望获得临床益处。在确定该申请符合加速审批的要求时，该机构得出结论，Aduhelm 对阿尔茨海默病患者的益处大于该疗法的风险。</blockquote> What the Data Show<blockquote>数据显示</blockquote> The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint. &nbsp;In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. &nbsp;It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.<blockquote>Aduhelm的后期开发计划包括两项3期临床试验。一项研究达到了主要终点，显示临床下降减少。第二次试验未达到主要终点。然而，在所有评估它的研究中，Aduhelm以剂量和时间依赖性的方式持续且非常令人信服地降低了大脑中淀粉样蛋白斑块的水平。预期淀粉样蛋白斑块的减少将导致临床下降的减少。</blockquote> We know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm application, did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval. The option of Accelerated Approval was not discussed by the Advisory Committee. As mentioned above, treatment with Aduhelm was clearly shown in all trials to substantially reduce amyloid beta plaques. This reduction in plaques is reasonably likely to result in clinical benefit. After the Advisory Committee provided its feedback, our review and deliberations continued, and we decided that the evidence presented in the Aduhelm application met the standard for Accelerated Approval. We thank the Advisory Committee for its independent review of the data and valuable advice.<blockquote>我们知道，外周和中枢神经系统药物咨询委员会于2020年11月召开会议，审查临床试验数据并讨论支持Aduhelm申请的证据，该委员会不同意将一项成功试验的临床获益视为支持批准的主要证据是合理的。咨询委员会没有讨论加速核准的备选办法。如上所述，用Aduhelm治疗在所有试验中都清楚地显示可显著减少β淀粉样蛋白斑块。这种斑块的减少合理地可能导致临床益处。在咨询委员会提供反馈后，我们继续进行审查和审议，我们决定Aduhelm申请中提出的证据符合加速批准的标准。我们感谢咨询委员会对数据的独立审查和宝贵意见。</blockquote> Accelerated Approval<blockquote>加速审批</blockquote> The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need.&nbsp; Approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain).&nbsp; A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.<blockquote>FDA制定了其加速批准计划，以允许早期批准治疗严重病症并满足未满足的医疗需求的药物。批准基于替代或中间临床终点（在这种情况下，减少大脑中的淀粉样蛋白斑块）。替代终点是标志物，例如实验室测量、放射线图像、物理标志或其他被认为预测临床益处但其本身不是临床益处的量度。使用替代终点可以大大缩短获得FDA批准所需的时间。</blockquote> Drug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.<blockquote>制药公司需要进行批准后研究，以验证预期的临床获益。这些研究被称为4期验证性试验。如果验证性试验没有验证该药物的预期临床益处，FDA 就会制定监管程序，这可能会导致该药物从市场上撤下。</blockquote> The Devastation of Alzheimer’s Disease<blockquote>阿尔茨海默病的毁灭性</blockquote> With all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimer’s disease causes, as patients lose their memory and cognitive functioning over time. In late-stage disease, people can no longer hold a conversation or respond to their environment. On average, a person with Alzheimer’s disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease.<blockquote>综上所述，我们非常清楚阿尔茨海默病会造成逐渐和累积的破坏，因为随着时间的推移，患者会失去记忆和认知功能。在疾病晚期，人们无法再进行对话或对环境做出反应。阿尔茨海默病患者在确诊后的平均寿命为四到八年，但有些患者的患病寿命可达 20 年。</blockquote> The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages. Alzheimer's is the sixth leading cause of death in the United States.<blockquote>治疗需求迫切： 目前，有 600 多万美国人患有阿尔茨海默病，随着人口老龄化，这一数字预计还会增加。阿尔茨海默氏症是美国第六大死因。</blockquote> Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients. &nbsp;As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease.<blockquote>尽管Aduhelm的数据在其临床益处方面很复杂，但FDA已经确定有大量证据表明Aduhelm减少了大脑中的淀粉样β斑块，并且这些斑块的减少有合理的可能预测对患者的重要益处。由于 FDA 批准了 Aduhelm，阿尔茨海默病患者有了一种重要而关键的新疗法来帮助对抗这种疾病。</blockquote> FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease.<blockquote>美国食品和药物管理局将继续对 Aduhelm 进行监控，直到它进入市场，并最终进入患者的床边。此外，美国食品和药物管理局还要求百健公司进行批准后临床试验，以验证该药物的临床益处。如果药物没有达到预期效果，我们可以采取措施将其从市场上撤下。但希望，随着越来越多的人接受Aduhelm，我们将在临床试验中看到更多的益处证据。作为一个机构，我们还将继续努力促进这种灾难性疾病的药物开发。</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>Controversial Biogen Alzheimer Drug Wins FDA Approval<blockquote>备受争议的百健阿尔茨海默病药物获得 FDA 批准</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\">\nControversial Biogen Alzheimer Drug Wins FDA Approval<blockquote>备受争议的百健阿尔茨海默病药物获得 FDA 批准</blockquote>\n</h2>\n<h4 class=\"meta\">\n\nzerohedge2021-06-07 23:48\n\n</h4>\n</header>\n<article>\nIn what could be a major coup for Biogen, the FDA on Monday approved Aduhelm (aducanumab), Biogen's experimental drug for treating the physiological causes of Alzheimer's, as the first treatment to address an underlying cause of the disease despite the remaining controversy over the drug's decidedly mixed clinical trial results.<blockquote>FDA 周一批准了 Biogen 用于治疗阿尔茨海默病生理原因的实验性药物 Aduhelm (aducanumab)，这可能是对百健 (Biogen) 来说的一个重大政变，尽管该药物的临床试验结果明显好坏参半，但仍有争议。</blockquote> AsReutersexplains, Aduhelm is one of a long list of drugs that have aimed to remove sticky deposits of a protein called amyloid beta from the brains of patients suffering from early-stage Alzheimer's in order to stave off the worst ravages of the disease, which is characterized by severe memory loss and the loss of the ability to care for oneself.<blockquote>正如路透社解释的那样，Aduhelm 是一长串旨在清除早期阿尔茨海默氏症患者大脑中一种称为淀粉样蛋白 β 的蛋白质粘性沉积物的药物之一，以避免该疾病最严重的破坏，其特征是严重的记忆力丧失和丧失自理能力。</blockquote> The clinical trials for Aduhelm were the first to show that a reduction in these plaques (which are considered a hallmark symptom of the disease) can slow the clinical decline of a patient.<blockquote>Aduhelm的临床试验首次表明，这些斑块（被认为是该疾病的标志性症状）的减少可以减缓患者的临床下降。</blockquote> The drug has created a rift in the professional community that was mentioned inthe FDA's press release: the agency said that the data included in the Biogen's submission - which were derived from two phase 3 clinical trials - were \"highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.\" Many scientists opposed the drug's approval, saying it doesn't work.<blockquote>该药物在专业界造成了裂痕，FDA 的新闻稿中提到了这一点：该机构表示，百健提交的材料中包含的数据（来自两项 3 期临床试验）“非常复杂，在临床益处方面留下了剩余的不确定性。关于 Aduhelm 是否应该获得批准，公众一直存在相当大的争论。正如在解释科学数据时经常发生的那样，专家界提出了不同的观点”。许多科学家反对该药物的批准，称其不起作用。</blockquote> As a result, Biogen will be required to conduct another round of post-approval clinical studies (what the FDA is calling a \"Phase 4\" trial).<blockquote>因此，百健将被要求进行另一轮批准后的临床研究（FDA称之为“4期”试验）。</blockquote> Biogen's new drug is the first Alzheimer's treatment approved since 2003. Existing treatment courses for the disease don't do much to arrest the underlying causes, but rather are designed to make patients more comfortable.<blockquote>百健的新药是自2003年以来第一个被批准的阿尔茨海默病治疗药物。该疾病的现有治疗方案并没有起到多大作用来阻止潜在的原因，而是旨在让患者更舒适。</blockquote> FDA approved Aduhelm to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, which allowed for the drug's approval thanks to the success it showed in reducing the amyloid beta brain plaque.<blockquote>美国食品和药物管理局批准 Aduhelm 使用加速批准途径治疗阿尔茨海默病患者，由于该药物在减少β淀粉样蛋白脑斑块方面取得了成功，因此获得了批准。</blockquote> Shares of Biogen climbed on the news, as did shares in other companies known to be working on alzheimer treatments, including Biogen rival Eli Lilly. The Nasdaq biotech index climbed to a session high.<blockquote>这一消息传出后，百健的股价上涨，其他已知从事阿尔茨海默氏症治疗的公司的股价也随之上涨，其中包括百健的竞争对手礼来公司。纳斯达克生物技术指数攀升至盘中高点。</blockquote> <img src=\"https://static.tigerbbs.com/ac26030030981a2daa2396729b972e22\" tg-width=\"500\" tg-height=\"337\">Read the full press release below:<blockquote>阅读下面的完整新闻稿：</blockquote> Today FDA approved&nbsp;Aduhelm (aducanumab)&nbsp;to treat patients with Alzheimer’s disease using the&nbsp;Accelerated Approval&nbsp;pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.<blockquote>今天，美国食品和药物管理局批准了 Aduhelm（aducanumab），使用加速批准途径治疗阿尔茨海默病患者，根据该途径，美国食品和药物管理局批准了一种治疗严重或危及生命疾病的药物，如果该药物被证明对替代终点产生影响，且该药物的临床益处仍存在一些不确定性，则该药物可能比现有治疗提供有意义的治疗益处。</blockquote> This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.&nbsp; The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.<blockquote>这一批准在很多方面都意义重大。Aduhelm 是自 2003 年以来获批治疗阿尔茨海默病的第一种新疗法。也许更重要的是，Aduhelm 是第一个针对阿尔茨海默病潜在病理生理学--大脑中存在 β 淀粉样蛋白斑块--的治疗方法。Aduhelm 的临床试验首次表明，这些斑块的减少--这是阿尔茨海默病患者大脑中的一个标志性发现--有望减少这种毁灭性痴呆症的临床下降。</blockquote> We are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.<blockquote>我们很清楚围绕这一批准的关注。我们了解到，Aduhelm 已经引起了媒体、阿尔茨海默氏症患者社区、我们的民选官员和其他相关利益相关者的关注。在对一种严重的、危及生命的疾病进行治疗的情况下，这么多人关注这篇综述的结果是有道理的。此外，申请人提交的材料中包含的数据非常复杂，在临床获益方面留下了剩余的不确定性。关于是否应该批准Aduhelm，公众进行了相当多的辩论。正如在解释科学数据时经常发生的那样，专家群体提供了不同的观点。</blockquote> At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. We examined the clinical trial findings with a fine-tooth comb, we solicited input from the&nbsp;Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.<blockquote>归根结底，在数据不明确的情况下做出监管决策时，我们遵循了通常的行动方针。我们用细齿梳子检查了临床试验结果，我们征求了外周和中枢神经系统药物咨询委员会的意见，我们听取了患者群体的观点，我们审查了所有相关数据。我们最终决定使用加速审批途径——该途径旨在为严重疾病患者提供更早获得潜在有价值的疗法的途径，这些患者的需求未得到满足，并且尽管存在一些关于该益处的剩余不确定性，但仍有望获得临床益处。在确定该申请符合加速审批的要求时，该机构得出结论，Aduhelm 对阿尔茨海默病患者的益处大于该疗法的风险。</blockquote> What the Data Show<blockquote>数据显示</blockquote> The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint. &nbsp;In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. &nbsp;It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.<blockquote>Aduhelm的后期开发计划包括两项3期临床试验。一项研究达到了主要终点，显示临床下降减少。第二次试验未达到主要终点。然而，在所有评估它的研究中，Aduhelm以剂量和时间依赖性的方式持续且非常令人信服地降低了大脑中淀粉样蛋白斑块的水平。预期淀粉样蛋白斑块的减少将导致临床下降的减少。</blockquote> We know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm application, did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval. The option of Accelerated Approval was not discussed by the Advisory Committee. As mentioned above, treatment with Aduhelm was clearly shown in all trials to substantially reduce amyloid beta plaques. This reduction in plaques is reasonably likely to result in clinical benefit. After the Advisory Committee provided its feedback, our review and deliberations continued, and we decided that the evidence presented in the Aduhelm application met the standard for Accelerated Approval. We thank the Advisory Committee for its independent review of the data and valuable advice.<blockquote>我们知道，外周和中枢神经系统药物咨询委员会于2020年11月召开会议，审查临床试验数据并讨论支持Aduhelm申请的证据，该委员会不同意将一项成功试验的临床获益视为支持批准的主要证据是合理的。咨询委员会没有讨论加速核准的备选办法。如上所述，用Aduhelm治疗在所有试验中都清楚地显示可显著减少β淀粉样蛋白斑块。这种斑块的减少合理地可能导致临床益处。在咨询委员会提供反馈后，我们继续进行审查和审议，我们决定Aduhelm申请中提出的证据符合加速批准的标准。我们感谢咨询委员会对数据的独立审查和宝贵意见。</blockquote> Accelerated Approval<blockquote>加速审批</blockquote> The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need.&nbsp; Approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain).&nbsp; A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.<blockquote>FDA制定了其加速批准计划，以允许早期批准治疗严重病症并满足未满足的医疗需求的药物。批准基于替代或中间临床终点（在这种情况下，减少大脑中的淀粉样蛋白斑块）。替代终点是标志物，例如实验室测量、放射线图像、物理标志或其他被认为预测临床益处但其本身不是临床益处的量度。使用替代终点可以大大缩短获得FDA批准所需的时间。</blockquote> Drug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.<blockquote>制药公司需要进行批准后研究，以验证预期的临床获益。这些研究被称为4期验证性试验。如果验证性试验没有验证该药物的预期临床益处，FDA 就会制定监管程序，这可能会导致该药物从市场上撤下。</blockquote> The Devastation of Alzheimer’s Disease<blockquote>阿尔茨海默病的毁灭性</blockquote> With all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimer’s disease causes, as patients lose their memory and cognitive functioning over time. In late-stage disease, people can no longer hold a conversation or respond to their environment. On average, a person with Alzheimer’s disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease.<blockquote>综上所述，我们非常清楚阿尔茨海默病会造成逐渐和累积的破坏，因为随着时间的推移，患者会失去记忆和认知功能。在疾病晚期，人们无法再进行对话或对环境做出反应。阿尔茨海默病患者在确诊后的平均寿命为四到八年，但有些患者的患病寿命可达 20 年。</blockquote> The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages. Alzheimer's is the sixth leading cause of death in the United States.<blockquote>治疗需求迫切： 目前，有 600 多万美国人患有阿尔茨海默病，随着人口老龄化，这一数字预计还会增加。阿尔茨海默氏症是美国第六大死因。</blockquote> Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients. &nbsp;As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease.<blockquote>尽管Aduhelm的数据在其临床益处方面很复杂，但FDA已经确定有大量证据表明Aduhelm减少了大脑中的淀粉样β斑块，并且这些斑块的减少有合理的可能预测对患者的重要益处。由于 FDA 批准了 Aduhelm，阿尔茨海默病患者有了一种重要而关键的新疗法来帮助对抗这种疾病。</blockquote> FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease.<blockquote>美国食品和药物管理局将继续对 Aduhelm 进行监控，直到它进入市场，并最终进入患者的床边。此外，美国食品和药物管理局还要求百健公司进行批准后临床试验，以验证该药物的临床益处。如果药物没有达到预期效果，我们可以采取措施将其从市场上撤下。但希望，随着越来越多的人接受Aduhelm，我们将在临床试验中看到更多的益处证据。作为一个机构，我们还将继续努力促进这种灾难性疾病的药物开发。</blockquote>\n<div class=\"bt-text\">\n\n\n 来源：<a href=\"https://www.zerohedge.com/markets/breakthrough-biogen-alzheimer-drug-wins-fda-approval?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+zerohedge%2Ffeed+%28zero+hedge+-+on+a+long+enough+timeline%2C+the+survival+rate+for+everyone+drops+to+zero%29\">zerohedge</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":{"BIIB":"渤健公司"},"source_url":"https://www.zerohedge.com/markets/breakthrough-biogen-alzheimer-drug-wins-fda-approval?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+zerohedge%2Ffeed+%28zero+hedge+-+on+a+long+enough+timeline%2C+the+survival+rate+for+everyone+drops+to+zero%29","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1133110564","content_text":"In what could be a major coup for Biogen, the FDA on Monday approved Aduhelm (aducanumab), Biogen's experimental drug for treating the physiological causes of Alzheimer's, as the first treatment to address an underlying cause of the disease despite the remaining controversy over the drug's decidedly mixed clinical trial results.\nAsReutersexplains, Aduhelm is one of a long list of drugs that have aimed to remove sticky deposits of a protein called amyloid beta from the brains of patients suffering from early-stage Alzheimer's in order to stave off the worst ravages of the disease, which is characterized by severe memory loss and the loss of the ability to care for oneself.\nThe clinical trials for Aduhelm were the first to show that a reduction in these plaques (which are considered a hallmark symptom of the disease) can slow the clinical decline of a patient.\nThe drug has created a rift in the professional community that was mentioned inthe FDA's press release: the agency said that the data included in the Biogen's submission - which were derived from two phase 3 clinical trials - were \"highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.\" Many scientists opposed the drug's approval, saying it doesn't work.\nAs a result, Biogen will be required to conduct another round of post-approval clinical studies (what the FDA is calling a \"Phase 4\" trial).\nBiogen's new drug is the first Alzheimer's treatment approved since 2003. Existing treatment courses for the disease don't do much to arrest the underlying causes, but rather are designed to make patients more comfortable.\nFDA approved Aduhelm to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, which allowed for the drug's approval thanks to the success it showed in reducing the amyloid beta brain plaque.\nShares of Biogen climbed on the news, as did shares in other companies known to be working on alzheimer treatments, including Biogen rival Eli Lilly. The Nasdaq biotech index climbed to a session high.\nRead the full press release below:\nToday FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.\nThis approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.  The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.\nWe are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.\nAt the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.\nWhat the Data Show\nThe late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint.  In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion.  It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.\nWe know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm application, did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval. The option of Accelerated Approval was not discussed by the Advisory Committee. As mentioned above, treatment with Aduhelm was clearly shown in all trials to substantially reduce amyloid beta plaques. This reduction in plaques is reasonably likely to result in clinical benefit. After the Advisory Committee provided its feedback, our review and deliberations continued, and we decided that the evidence presented in the Aduhelm application met the standard for Accelerated Approval. We thank the Advisory Committee for its independent review of the data and valuable advice.\nAccelerated Approval\nThe FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need.  Approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain).  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.\nDrug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.\nThe Devastation of Alzheimer’s Disease\nWith all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimer’s disease causes, as patients lose their memory and cognitive functioning over time. In late-stage disease, people can no longer hold a conversation or respond to their environment. On average, a person with Alzheimer’s disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease.\nThe need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages. Alzheimer's is the sixth leading cause of death in the United States.\nAlthough the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients.  As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease.\nFDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease.","news_type":1,"symbols_score_info":{"BIIB":0.9}},"isVote":1,"tweetType":1,"viewCount":3342,"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":10,"subscribersOnly":false,"subscribersOnlyAccessible":false,"xxTargetLangEnum":"ORIG"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/114481303"}