Open Peer Commentary to "Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE Trials as reported by Biogen December 2019".

Open Peer Commentary to "Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE Trials as reported by Biogen December 2019".
复制标题

DOI:
10.1002/alz.12235
复制
发表时间:
2021-04
期刊:
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子:
--
通讯作者:
Cummings J
Cummings J
中科院分区:
其他
文献类型:
--
作者:
Sabbagh MN;Cummings J

文献摘要

参考文献

被引文献

相似文献

通过充分披露,MNS建议Biogen的aducanumab,Questai的BAN 2401计划,Roche的Gantanerumab,Alzheon的Alz 801计划,Cortexyme COR 388计划和Athira的NDX 1017。过去,MNS是辉瑞/惠氏Bapineuzemab项目的指导委员会成员,并为礼来的solanazumab和Axovant的Interpredine项目和VTV治疗Azeliragon项目提供咨询。本公开旨在提高透明度,并向读者提供对aducanumab无排他性偏见的观点。Cummings博士曾为以下公司提供咨询服务:Alcadia、Actinogen、Acumen、Alector、Alkahest、Alzheon、AriBio、Avanir、Axsome、贝伦治疗公司、Biogen、Cassava、Cerecin、Cerevel、Cortexyme、Cytox、EIP Pharma、Genomai、Foclonal、GemVax、Genentech、绿色谷、Grifols、杨森、Karuna、默克、诺和诺德、大冢、ReMYND、Resverlogix、罗氏、Samumed、Samus、Signant Health、Sunovion、Suven、和联合神经科学制药和评估公司。美国食品和药物管理局(FDA)咨询委员会将很快审查Biogen提交的数据,以批准aducanumab用于减缓阿尔茨海默病(AD)的进展。如果获得批准,aducanumab将成为自2003年以来在美国批准的第一种AD治疗药物,第一种治疗AD引起的轻度认知障碍的药物,第一种批准的靶向淀粉样蛋白的药物,以及第一种具有治疗AD的假定疾病修饰机制的药物。在这一期的阿尔茨海默氏症和痴呆症中,Knopman博士及其同事1挑战了aducanumab的疗效数据。鉴于必须
By full disclosure, MNS advises Biogen’s aducanumab, Eisai’s BAN2401 program, Roche’s Gantanerumab, Alzheon’s Alz801 program, Cortexyme COR388 program, and Athira’s NDX1017. In the past, MNS was on the steering committee of the Pfizer/Wyeth Bapineuzemab program and advised Lilly’s solanazumab and Axovant’s Interpredine program and VTV therapeutics Azeliragon program. This disclosure is intended for transparency and to give the reader the perspective of no exclusionary bias toward or against aducanumab. Dr. Cummings has provided consultation to Acadia, Actinogen, Acumen, Alector, Alkahest, Alzheon, AriBio, Avanir, Axsome, Behren Therapeutics, Biogen, Cassava, Cerecin, Cerevel, Cortexyme, Cytox, EIP Pharma, Eisai, Foresight, GemVax, Genentech, Green Valley, Grifols, Janssen, Karuna, Merck, Novo Nordisk, Otsuka, ReMYND, Resverlogix, Roche, Samumed, Samus, Signant Health, Sunovion, Suven, and United Neuroscience pharmaceutical and assessment companies. A US Food and Drug Administration (FDA) Advisory Committee will soon review data submitted by Biogen for approval of aducanumab for the slowing progression of Alzheimer’s disease (AD). If approved, aducanumab will be the first of treatment for AD approved in the US since 2003, the first treatment for mild cognitive impairment due to AD, the first approved agent to target the amyloid protein, and the first drug with a putative disease-modifying mechanism for the treatment of AD. In this issue of Alzheimer’s & Dementia, Dr. Knopman and colleagues 1 challenge the efficacy data of aducanumab. In view of the importance of
DOI: 10.1056/nejmoa1304839
发表时间: 2014-01-23
期刊: The New England journal of medicine
影响因子: --
作者:
Salloway S;Sperling R;Fox NC;Blennow K;Klunk W;Raskind M;Sabbagh M;Honig LS;Porsteinsson AP;Ferris S;Reichert M;Ketter N;Nejadnik B;Guenzler V;Miloslavsky M;Wang D;Lu Y;Lull J;Tudor IC;Liu E;Grundman M;Yuen E;Black R;Brashear HR;Bapineuzumab 301 and 302 Clinical Trial Investigators
通讯作者: Bapineuzumab 301 and 302 Clinical Trial Investigators
DOI: 10.4103/1995-705x.95070
发表时间: 2011-07-01
期刊: Heart views : the official journal of the Gulf Heart Association
影响因子: --
作者:
Hajar, Rachel
通讯作者: Hajar, Rachel
DOI: 10.1038/nature19323
发表时间: 2016-09-01
期刊: NATURE
影响因子: 64.8
作者:
Sevigny, Jeff;Chiao, Ping;Sandrock, Alfred
通讯作者: Sandrock, Alfred
DOI: 10.1038/s41594-020-0505-6
发表时间: 2020-09-28
影响因子: 16.8
作者:
Linse, Sara;Scheidt, Tom;Hansson, Oskar
通讯作者: Hansson, Oskar
DOI: 10.1056/nejmoa1705971
发表时间: 2018-01-25
影响因子: 158.5
作者:
Honig, Lawrence S.;Vellas, Bruno;Siemers, Eric
通讯作者: Siemers, Eric