礼来(LLY.US)阿尔茨海默氏症药获美国FDA批准与渤健(BIIB.US)展开两强争霸！

智通财经07-03

智通财经获悉，礼来(LLY.US)研发的药物“donanemab-azbt”被美国食品和药物管理局(FDA)批准用于治疗有轻度认知障碍的阿尔茨海默病早期患者，商品名为“Kisunla”。根据阿尔茨海默病协会的数据，近700万美国人患有这种疾病，是65岁以上老年人的第五大死因。到2050年，美国的这一群体预计将增加到近1300万人这是礼来期待已久的胜利，此前donanemab在进入市场的道路上遇到了...

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hegemony!","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"BIIB":1,"LLY":1},"content_text":"智通财经获悉，礼来(LLY.US)研发的药物“donanemab-azbt”被美国食品和药物管理局(FDA)批准用于治疗有轻度认知障碍的阿尔茨海默病早期患者，商品名为“Kisunla”。根据阿尔茨海默病协会的数据，近700万美国人患有这种疾病，是65岁以上老年人的第五大死因。到2050年，美国的这一群体预计将增加到近1300万人这是礼来期待已久的胜利，此前donanemab在进入市场的道路上遇到了障碍。由于数据不足，FDA去年拒绝了该药的批准，然后令人惊讶地在3月份再次推迟了批准。上个月，该机构的一个顾问小组建议全面批准该疗法，称其益处大于风险。礼来表示，患者每四周静脉输注一次Kisunla，每瓶售价为695.65美元，6个月疗程的费用为12,522美元，12个月疗程的费用为32,000美元，18个月疗程的费用为48,696美元。礼来公司表示，符合条件的患者可以获得医疗保险覆盖和报销。“双雄争霸”阿尔茨海默病治疗领域Donanemab将与渤健(BIIB.US)及其日本合作伙伴卫材药业的另一种治疗药物Leqembi展开正面竞争。Leqembi自去年夏天获得批准以来，已逐步在美国推出。阿尔茨海默氏症协会主席兼首席执行官Joanne Pike说：“这是真正的进步。今天的批准允许人们有更多的选择和更多的机会，有更多的时间。拥有多种治疗选择是我们所有人一直在等待的进步。”Donanemab和Leqembi是治疗阿尔茨海默氏症的里程碑，此前三十年，人们一直在努力开发对抗这种致命疾病的药物，但都失败了。这两种药物都靶向阿尔茨海默病患者大脑中的β淀粉样蛋白，而脑部β淀粉样蛋白异常沉积是阿尔茨海默病主要病理特征之一，可以减缓早期患者疾病的进展。有分析人士预计，donanemab可能优于Leqembi，因为其在试验中显示出了更高的疗效。Donanemab与名为N3pG的β淀粉样蛋白亚型结合，可以帮助患者完成斑块清除。在三期试验中，相较安慰剂组，Leqembi减缓了27%的认知能力下降，donanemab则在18个月内减缓了35%的认知能力下降。在达到清除淀粉样斑块的特定目标后，患者可以在6个月、12个月或18个月后结束治疗，转而服用安慰剂。但两种治疗方法都不能治愈。针对并清除淀粉样斑块的药物也有很大的安全风险，包括大脑肿胀和出血，在某些情况下，这可能是严重的，甚至是致命的。在一项后期试验中，三名服用礼来公司药物的患者死于严重的副作用，即淀粉样蛋白相关成像异常(ARIA)。礼来的药物是继渤健和卫材的Leqembi和Aduhelm之后第三个进入市场的同类药物。这两家公司最近放弃了Aduhelm。FDA因在2021年加速批准Aduhelm而受到批评，尽管咨询小组提出了负面建议。","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 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礼来(LLY.US)阿尔茨海默氏症药获美国FDA批准 与渤健(BIIB.US)展开两强争霸！

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礼来(LLY.US)阿尔茨海默氏症药获美国FDA批准与渤健(BIIB.US)展开两强争霸！