Eisai和Biogen正在向FDA申请aducanumab治疗阿尔茨海默症的优先审查

2020-08-09 Allan MedSci原创

制药公司百健(Biogen)和卫材(Eisai)近日表示,FDA接受了aducanumab治疗阿尔茨海默症优先审查的申请,并将目标行动日期定为明年3月7日。

制药公司百健(Biogen)和卫材(Eisai)近日表示,FDA接受了aducanumab治疗阿尔茨海默症优先审查的申请,并将目标行动日期定为明年3月7日。两家公司指出,该机构还打算举行一次咨询委员会会议,以讨论该提案,并补充说,如果可能的话,监管机构计划尽早采取行动。

Aducanumab(BIIB037)是一种研究性人类单克隆抗体,已被研究用于治疗早期阿尔茨海默氏病。根据合作开发和许可协议,Biogen从Neurimmune获得了aducanumab。自2017年10月以来,百健(Biogen)和卫材(Eisai)在全球范围内合作开展了aducanumab的开发和商业化。

EMERGE和ENGAGE是III期多中心、随机、双盲、安慰剂对照、平行组研究,旨在评估aducanumab的疗效和安全性。这项研究的主要终点是评估每月剂量的aducanumab与安慰剂相比在减少认知和功能障碍方面的功效,这是通过CDR-SB评分的变化来衡量的。次要终点是评估aducanumab与安慰剂相比对MMSE、ADAS-Cog 13和ADCS-ADL-MCI评分变化的影响。详细见:Biogen的aducanumab治疗阿尔茨海默氏病符合III期试验终点

阿尔茨海默症俗称早老性痴呆、老年痴呆,是一种发病进程缓慢、随着时间不断恶化的神经退化性疾病,此病症占了痴呆症中六到七成的成因。最常见的早期症状为丧失短期记忆(难以记住最近发生的事),当疾病逐渐进展,症状可能逐渐出现,包括语言障碍、定向障碍(包括容易迷路)、情绪不稳、丧失动机、无法自理和许多行为问题。

 

原始出处:

https://www.firstwordpharma.com/node/1747363?tsid=4

Frost CV, Zacharias M. From monomer to fibril: Abeta-amyloid binding to Aducanumab antibody studied by molecular dynamics simulation.Proteins. 2020 Jul 14. doi: 10.1002/prot.25978.

Mullane K, Williams M.Alzheimer's disease beyond amyloid: Can the repetitive failures of amyloid-targeted therapeutics inform future approaches to dementia drug discovery?Biochem Pharmacol. 2020 Jul;177:113945

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    2020-08-12 snf701207
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    2021-04-04 sunylz
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  5. [GetPortalCommentsPageByObjectIdResponse(id=1912422, encodeId=2ddc1912422a3, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Aug 12 15:07:44 CST 2020, time=2020-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1817016, encodeId=cebd181e01655, content=<a href='/topic/show?id=17b59e77626' target=_blank style='color:#2F92EE;'>#阿尔茨#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97776, encryptionId=17b59e77626, topicName=阿尔茨)], attachment=null, authenticateStatus=null, 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encodeId=0f2f81065030, content=💯💯💯, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=caa55135459, createdName=14665664m21暂无昵称, createdTime=Wed Aug 19 13:27:15 CST 2020, time=2020-08-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1400163, encodeId=1dba1400163be, content=<a href='/topic/show?id=0b0e25e2913' target=_blank style='color:#2F92EE;'>#优先审查#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25729, encryptionId=0b0e25e2913, topicName=优先审查)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=80942248041, createdName=yxch37, createdTime=Tue Aug 11 03:07:44 CST 2020, time=2020-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1404349, encodeId=61b0140434998, content=<a href='/topic/show?id=a4f13430af' target=_blank style='color:#2F92EE;'>#Biogen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3430, encryptionId=a4f13430af, topicName=Biogen)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0dab2457651, createdName=qjddjq, createdTime=Tue Aug 11 03:07:44 CST 2020, time=2020-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470393, encodeId=286314e0393fb, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Tue Aug 11 03:07:44 CST 2020, time=2020-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=807255, encodeId=886680e255b4, content=受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d095409783, createdName=ms5000002046462755, createdTime=Mon Aug 10 11:54:32 CST 2020, time=2020-08-10, status=1, ipAttribution=)]
    2020-09-06 彭红

    重点看疗效

    0

  6. 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content=<a href='/topic/show?id=a4f13430af' target=_blank style='color:#2F92EE;'>#Biogen#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3430, encryptionId=a4f13430af, topicName=Biogen)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=0dab2457651, createdName=qjddjq, createdTime=Tue Aug 11 03:07:44 CST 2020, time=2020-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1470393, encodeId=286314e0393fb, content=<a href='/topic/show?id=45a79e7788c' target=_blank style='color:#2F92EE;'>#阿尔茨海默#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97778, encryptionId=45a79e7788c, topicName=阿尔茨海默)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c5917090900, createdName=yhj-time, createdTime=Tue Aug 11 03:07:44 CST 2020, time=2020-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=807255, encodeId=886680e255b4, content=受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d095409783, createdName=ms5000002046462755, createdTime=Mon Aug 10 11:54:32 CST 2020, time=2020-08-10, status=1, ipAttribution=)]
    2020-08-19 14665664m21暂无昵称

    💯💯💯

    0

  7. 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time=2020-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=807255, encodeId=886680e255b4, content=受益匪浅, beContent=null, objectType=article, channel=null, level=null, likeNumber=89, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=6d095409783, createdName=ms5000002046462755, createdTime=Mon Aug 10 11:54:32 CST 2020, time=2020-08-10, status=1, ipAttribution=)]
    2020-08-11 qjddjq
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    2020-08-10 ms5000002046462755

    受益匪浅

    0

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拓展阅读

FDA顾问小组不支持阿尔茨海默氏病药物aducanumab

近日,FDA顾问小组对Biogen和Eisai的抗淀粉样蛋白抗体aducanumab的批准投了反对票,小组认为,鉴于与另一项试验的结果相互矛盾,单项阳性研究的证据不足以证明该药对阿尔茨海默氏病的疗效。

阿尔茨海默症新药aducanumab上市申请又有新动态

日前,渤健和卫材联合宣布,欧洲药品管理局(EMA)已确认接受阿尔茨海默病研究性治疗药物aducanumab的上市授权申请(MAA),如若获得批准,aducanumab将成为减少阿尔茨海默氏病临床下降的

Biogen的aducanumab治疗阿尔茨海默氏病符合III期试验终点

在与美国食品和药物管理局(FDA)协商后,Biogen计划寻求aducanumab(早期阿尔茨海默氏病AD的研究治疗药物)的监管批准。该公司表示,计划在2020年初提交生物制品许可申请(BLA)。BLA提交的内容将包括I/Ib期研究的数据以及III期研究的完整数据。

Biogen将向FDA申请阿尔茨海默症治疗药物Aducanumab的监管备案

Biogen和日本Eisai今天宣布将向美国食品药品监督管理局申请针早期阿尔茨海默病治疗药物aducanumab的生物制品许可上市申请。