阿尔茨海默病轻度痴呆有药治了！

界面2024-12-18

界面新闻记者 |唐卓雅界面新闻编辑 |谢欣12月18日，礼来宣布，该公司1类新药记能达®（多奈单抗注射液）上市申请已获得中国国家药监局批准。多奈单抗注射液获批用于治疗成人因阿尔茨海默病引起的轻度认知功能障碍和阿尔茨海默病轻度痴呆。礼来称，多奈单抗注射液是唯一一个有证据支持在清除淀粉样蛋白斑块后可停药的靶向淀粉样蛋白的疗法。该药是一种处方药，每四周静脉输注一次，前三次剂量为700毫克，随后为1400...

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|谢欣12月18日，礼来宣布，该公司1类新药记能达®（多奈单抗注射液）上市申请已获得中国国家药监局批准。多奈单抗注射液获批用于治疗成人因阿尔茨海默病引起的轻度认知功能障碍和阿尔茨海默病轻度痴呆。礼来称，多奈单抗注射液是唯一一个有证据支持在清除淀粉样蛋白斑块后可停药的靶向淀粉样蛋白的疗法。该药是一种处方药，每四周静脉输注一次，前三次剂量为700毫克，随后为1400毫克。此前在今年7月，多奈单抗注射液率先在美国，而中国则是继美国、日本、英国批准多奈单抗注射液上市的又一全球主要市场。据礼来介绍，此次获批是基于TRAILBLAZER-ALZ 2三期临床研究的疗效和安全性数据。TRAILBLAZER-ALZ 2三期研究显示，疾病更早阶段患者使用多奈单抗注射液的效果更好。在疾病进展较早的人群中，接受多奈单抗注射液治疗的患者在综合阿尔茨海默病评分量表（iADRS），包含记忆、思维和日常功能的衰退速度与安慰剂相比显著减缓了35%。简单来说，与安慰剂相比，记能达®减缓了最高达35%的认知和功能衰退，同时，针对疾病更早阶段受试者，记能达®在18个月内降低了最高达39%的疾病进展风险。依据iADRS量表，在整体人群中，药物治疗则显著减缓了22%。在两组受试者中，接受多奈单抗注射液治疗的受试者比接受安慰剂的受试者展现了高达39%的降低疾病进展至下一临床阶段的风险。在整体受试者人群中，与研究开始时相比，使用多奈单抗注射液6个月时平均减少了61%的淀粉样蛋白斑块。阿尔茨海默病是一种会导致记忆力和其他认知功能逐渐衰退的致命性疾病，并且是主要的致死疾病之一。据估计，全球有3200万人患有阿尔茨海默病痴呆，并有确诊的淀粉样蛋白病理学改变。中国当前有近983万阿尔茨海默病患者。并且，中国因痴呆导致的死亡总数的排名已从1990年的第十位上升至2019年的第五位。近两年，被称为“研发坟场”的阿尔兹海默症进展颇多。去年7月，美国食品药品监督管理局（FDA）宣布，完全批准日本卫材和美国渤健联合开发的阿尔茨海默病（AD）新药lecanemab（仑卡奈单抗）上市。这是20年来首款获得FDA完全批准的阿尔茨海默病新药。今年1月，仑卡奈单抗也已经在国内获批上市。实际上，礼来的多奈单抗本与仑卡奈单抗进展相近，但是2023年1月FDA加速批准仑卡奈单抗的同时，拒绝加速批准多奈单抗，原因是礼来递交的2期临床TRAILBLAZER-ALZ研究中，接受至少12个月多奈单抗持续治疗的患者数据有限。之后该药又遭遇了两次监管审批延期。此后FDA又专门召开外部专家会议评估该药的有效性和安全性。此外，多奈单抗的安全性问题也受到关注。安全性方面，多奈单抗治疗组和安慰剂组的死亡率分别为1.9%、1.1%；严重不良事件发生率分别为17.4%、15.8%。另外，淀粉样蛋白相关成像异常（ARIA）是同类药物常见的副作用。其中，多奈单抗治疗组在淀粉样蛋白相关脑水肿（ARIA-E）和淀粉样蛋白相关微出血（ARIA-H）上的发生率分别为24%、19.7%，而这两个数据在安慰剂组分别为1.9%和7.4%。礼来也警示称，多奈单抗可引起淀粉样蛋白相关影像学异常（ARIA），这是淀粉样斑块靶向疗法的潜在副作用，通常不会引起症状。它可以通过磁共振成像（MRI） 扫描检测到，当它确实发生时，可能表现为大脑一个或多个区域的暂时肿胀，通常会随着时间的推移而消退，或者表现为大脑内部或表面的小出血点。在极少数情况下，脑部出血面积较大，可能会发生危及生命的事件。多奈单抗还会引起某些类型的过敏反应，其中一些可能很严重并危及生命，通常发生在输注期间或输注后30分钟内。头痛是另一个常见的副作用。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"2","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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