Aducanumab produced a clinically meaningful benefit in association with amyloid lowering

• Published in: Alzheimer's research & therapy Vol. 13; no. 1; pp. 98 - 3
• Main Authors: Cummings, Jeffrey, Aisen, Paul, Lemere, Cynthia, Atri, Alireza, Sabbagh, Marwan, Salloway, Stephen
• Format: Journal Article
• Language: English
• Published: London BioMed Central 10.05.2021; BioMed Central Ltd; BMC
• Subjects: 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; United States; United States > US; FDA; Lecanemab; Gantenerumab; Clinical trials; Monoclonal antibodies; Donanemab; Aducanumab
• ISSN: 1758-9193; 1758-9193
• DOI: 10.1186/s13195-021-00838-z

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.