18年来首个“老年痴呆症”药物获批，这意味着什么？

华尔街见闻2021-06-08

发生了什么？6月7日，美国渤健公司(Biogen Inc.)$(BIIB)$旗下的阿尔茨海默症药物获批上市，这是2003年来首款获美国食品和药物管理局批准的此类药物，然而目前围绕该药物的争议依然很大。这款药物的通用名为aducanumab，将以Aduhelm的商品名进行销售。渤健每年对这种药物的收费为5.6万美元，并且承诺至少四年内不涨价。据介绍，该药物具有清除大脑淀粉样蛋白斑块的能力，被认为可以...

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Comment（14）

Fred_6810
·2021-06-12
希望真的有效。
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大家好我是王剛88888
·2021-06-09
Buy
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浴缸潜水员
·2021-06-08
今年諾獎有戲。
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1
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- 小甘多多:
  [微笑]
  2021-06-08
  Reply
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yonglee7
·2021-06-08
[財迷] [財迷] [財迷]
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风雪腊梅
·2021-06-08
[開心] [開心] [開心]
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2
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远离中丐
·2021-06-08
意味着老年化問題會越來越嚴重
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罗宾王1988
·2021-06-08
?
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Kevin29
·2021-06-08
意味着？越來越多老年癡呆了嗎？
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宛莹
·2021-06-08
真的嗎？[笑哭]
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鹅蛋
·2021-06-08
特朗普也需要
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就要欺负你
·2021-06-08
剛好可以給拜登用上
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6
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求金
·2021-06-08
[暗中觀察]
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Bluez
·2021-06-08
意味着可以醫了
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- 小虎发财Replying toBluez:
  对?期待医学对人们的贡献感恩
  2021-06-11
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- Bluez:
  Yes
  2021-06-11
  Reply
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- 小虎发财:
  ?如果真的可以那太好了?
  2021-06-08
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小虎发财
·2021-06-08
???
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Moussa对MarketWatch表示：“阿尔茨海默症是我们所知道的最难以置信的疾病之一。”Moussa称对这种疾病的研究必须进行划分，以便更深入地挖掘大脑是如何运作的，为什么化学物质不能正确地传播，对日常生活活动(如洗澡和穿衣服)的影响，以及病人及其照顾者的生活质量。他说：“现在Aduhelm的批准就是打开潘多拉的盒子。”也有观点认为，这款药物的上市将改变阿尔茨海默症目前的治疗方式，至少对一些患者来说是这样，FDA的批准可能会为未来的治疗铺平道路。圣路易斯华盛顿大学(Washington University in St. Louis)的神经学家Erik Musiek在接受彭博采访中表示，如果FDA愿意接受淀粉样蛋白的减少作为批准的充分证据，这可能为其他药物打开大门，“如果你所需要的只是清理斑块，那肯定是另一种情况。”美国阿尔茨海默症协会首席执行官Harry Johns表示，“对于阿尔茨海默症患者来说，这只是新的一天，我们相信这将推动更多的创新和投资。”为什么分歧巨大？目前，围绕Aduhelm还存在着巨大的争议和不确定性，这款药物要使患者真正获益，还有很长的路要走。尽管获得FDA批准上市，但关于这种治疗方法仍有许多未知之处，目前并没有确凿的证据表明该药物减缓了记忆和大脑功能的衰退。而且这是一种必须在医生办公室使用的静脉注射药物，并可能出现脑肿胀和出血等副作用。据彭博，在渤健公司进行的一项大型试验中，该药物总体上是无效的。在另一项类似的研究中，高剂量的药物在18个月内将疾病的发展速度仅降低了22%。而部分临床医生对此药物同样抱有怀疑态度。据CNBC，部分医生表示，由于支撑Aduhelm的临床数据喜忧参半，如果该药品真的上市，他们不会在处方中开出此药。美国医生John DenBoer在接受MarketWatch采访中表示，尽管这是一个乐观的时刻，但FDA的批准只是制药公司在开发药物时面临的众多障碍之一，而且“批准并不意味着有效”。DenBoer是Smart Brain Aging公司的首席执行官，也是电影《这是痴呆症》(This is Dementia)的制片人。许多众所周知的“抗阿尔茨海默症”药物都失败了。DenBoer警告说，这种疗法在任何阶段都不能治愈或部分逆转阿尔茨海默氏症——这些目标都是不切实际的，至少对于目前正在对抗阿尔茨海默氏症的研究人员来说是如此：目前我们所使用的最好的药物最多只有5%的疗效，而且仅在疾病的早期阶段。如果你能在早期将这种疾病的强度降低10%，这将对许多人产生真正的影响，并改变他们的生活，我认为这是一个非常令人钦佩的目标。不过需要注意的是，FDA本次批准Aduhelm并非完全无条件，而是需要进行“第四阶段”临床研究。对此，FDA在新闻稿当中表示，渤健提交的材料中来自于两项三期临床试验的数据非常复杂，而且仍有不确定性残留。根据FDA的说法，“如果验证性试验不能证实该药物预期的临床效益”，该机构和制药公司可能会将该药物撤出市场。但是在验证性试验进行期间，渤健仍然可以出售Aduhelm。","kind":null,"is_publish_news":false,"is_publish_highlight":true,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[{"id":186041991,"gmtCreate":1623466804613,"gmtModify":1704204435074,"author":{"id":"3563140991934227","authorId":"3563140991934227","authorIdStr":"3563140991934227","name":"Fred_6810","avatar":"https://static.tigerbbs.com/fbe236f23155302a4dcecbf04d2e9040","vip":1,"crmLevel":7,"crmLevelSwitch":0,"idStr":"3563140991934227"},"htmlText":"希望真的有效。","listText":"希望真的有效。","text":"希望真的有效。","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/186041991","repostId":2141259936,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"CN"},{"id":180577303,"gmtCreate":1623216035202,"gmtModify":1704198557660,"author":{"id":"3568341343298894","authorId":"3568341343298894","authorIdStr":"3568341343298894","name":"大家好我是王剛88888","avatar":"https://static.tigerbbs.com/d84a1454474c28ae62985e96195561d3","vip":1,"crmLevel":5,"crmLevelSwitch":0,"idStr":"3568341343298894"},"htmlText":"Buy","listText":"Buy","text":"Buy","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/180577303","repostId":2141259936,"repostType":2,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"langContent":"EN"},{"id":117292166,"gmtCreate":1623141936755,"gmtModify":1704196931180,"author":{"id":"3532132223347993","authorId":"3532132223347993","authorIdStr":"3532132223347993","name":"浴缸潜水员","avatar":"https://static.tigerbbs.com/b4d01d6abe944b89aee8c87b329e931f","vip":1,"crmLevel":2,"crmLevelSwitch":1,"idStr":"3532132223347993"},"htmlText":"今年諾獎有戲。","listText":"今年諾獎有戲。","text":"今年諾獎有戲。","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":1,"commentSize":1,"repostSize":0,"link":"https://ttm.financial/post/117292166","repostId":2141259936,"repostType":4,"isVote":1,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"tweetType":1,"comments":[{"id":4635176,"gmtCreate":1623161916330,"gmtModify":1663228208831,"authorId":3574148235876178,"author":{"id":3574148235876178,"authorId":3574148235876178,"name":"小甘多多","avatar":"https://static.tigerbbs.com/34276edc2e67103fc93cfbaf5264eac6","vip":1,"crmLevel":2,"crmLevelSwitch":0,"individualDisplayBadges":[]},"repliedAuthorId":0,"objectId":117292166,"type":1,"supId":0,"prevId":0,"content":"[微笑]","text":"[微笑]","html":"[微笑]"}],"langContent":"CN"},{"id":117189874,"gmtCreate":1623122463398,"gmtModify":1704196545711,"author":{"id":"3585356839802810","authorId":"3585356839802810","authorIdStr":"3585356839802810","name":"yonglee7","avatar":"https://static.tigerbbs.com/8accecec1ddca2ff5d0b1ba4e54edbca","vip":1,"crmLevel":2,"crmLevelSwitch":0,"idStr":"3585356839802810"},"htmlText":"[財迷]&nbsp;[財迷]&nbsp;[財迷]&nbsp;","listText":"[財迷]&nbsp;[財迷]&nbsp;[財迷]&nbsp;","text":"[財迷] 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