Aducanumab produced a clinically meaningful benefit in association with amyloid lowering
Biogen submitted the data to the US Food and Drug Administration (FDA) for review and possible marketing approval, setting the stage for a vigorous dialogue on aducanumab [4, 5]. The CDR-sb, comprising the primary outcome of ENGAGE and EMERGE, is a composite measure with cognitive and functional com...
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| Published in | Alzheimer's research & therapy Vol. 13; no. 1; pp. 98 - 3 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London
BioMed Central
10.05.2021
BioMed Central Ltd BMC |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1758-9193 1758-9193 |
| DOI | 10.1186/s13195-021-00838-z |
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| Abstract | Biogen submitted the data to the US Food and Drug Administration (FDA) for review and possible marketing approval, setting the stage for a vigorous dialogue on aducanumab [4, 5]. The CDR-sb, comprising the primary outcome of ENGAGE and EMERGE, is a composite measure with cognitive and functional components including home activities, problem solving, and community engagement—skills highly valued by patients [6]. Disease-modifying therapies change the trajectory of disease progression; benefits observed in trials are anticipated to increase with long-term treatment. Based on the review of the totality of the data and our extensive experience with AD trials, research, and clinical care of patients and families, we conclude that aducanumab achieves the standard of meaningful efficacy with adequate safety in early AD. |
|---|---|
| AbstractList | Keywords: Aducanumab, FDA, Clinical trials, Monoclonal antibodies, Lecanemab, Donanemab, Gantenerumab Biogen submitted the data to the US Food and Drug Administration (FDA) for review and possible marketing approval, setting the stage for a vigorous dialogue on aducanumab [4, 5]. The CDR-sb, comprising the primary outcome of ENGAGE and EMERGE, is a composite measure with cognitive and functional components including home activities, problem solving, and community engagement—skills highly valued by patients [6]. Disease-modifying therapies change the trajectory of disease progression; benefits observed in trials are anticipated to increase with long-term treatment. Based on the review of the totality of the data and our extensive experience with AD trials, research, and clinical care of patients and families, we conclude that aducanumab achieves the standard of meaningful efficacy with adequate safety in early AD. |
| ArticleNumber | 98 |
| Audience | Academic |
| Author | Aisen, Paul Lemere, Cynthia Atri, Alireza Sabbagh, Marwan Salloway, Stephen Cummings, Jeffrey |
| Author_xml | – sequence: 1 givenname: Jeffrey orcidid: 0000-0001-8944-4158 surname: Cummings fullname: Cummings, Jeffrey email: jcummings@cnsinnovations.com organization: Chambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas (UNLV) – sequence: 2 givenname: Paul surname: Aisen fullname: Aisen, Paul organization: University of Southern California – sequence: 3 givenname: Cynthia surname: Lemere fullname: Lemere, Cynthia organization: Ann Romney Center for Neurologic Diseases, Brigham and Women’s Hospital, Harvard Medical School – sequence: 4 givenname: Alireza surname: Atri fullname: Atri, Alireza organization: Banner Sun Health Research Institute, Banner Health, Center for Brain/Mind Medicine, Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School – sequence: 5 givenname: Marwan surname: Sabbagh fullname: Sabbagh, Marwan organization: Cleveland Clinic Lou Ruvo Center for Brain Health – sequence: 6 givenname: Stephen surname: Salloway fullname: Salloway, Stephen organization: Butler Hospital and Brown University |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33971962$$D View this record in MEDLINE/PubMed |
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| SubjectTerms | Activities of daily living Aducanumab Alzheimer Disease - drug therapy Alzheimer's disease Amyloid Amyloid beta-Peptides Amyloidogenic Proteins Antibodies, Monoclonal, Humanized Biological products industry Biomedical and Life Sciences Biomedicine Blood-brain barrier Brain research Clinical trials Cognition & reasoning Dementia Donanemab Drug dosages Drug therapy FDA Geriatric Psychiatry Geriatrics/Gerontology Humans Lecanemab Monoclonal antibodies Neurology Neurosciences Product development Viewpoint |
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| Title | Aducanumab produced a clinically meaningful benefit in association with amyloid lowering |
| URI | https://link.springer.com/article/10.1186/s13195-021-00838-z https://www.ncbi.nlm.nih.gov/pubmed/33971962 https://www.proquest.com/docview/2528918218 https://www.proquest.com/docview/2525650268 https://pubmed.ncbi.nlm.nih.gov/PMC8111757 https://doaj.org/article/b9e5f91eadd04fcdb1c0bac44c4e5eca |
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