Results 151 to 160 of about 5,337 (191)
Aducanumab—Hope or Disappointment for Alzheimer’s Disease
In June 2021, the world was informed about a new drug for Alzheimer’s disease approved by the FDA. Aducanumab (BIIB037, ADU), being a monoclonal antibody IgG1, is the newest AD treatment. The activity of the drug is targeted towards amyloid β, which is considered one of the main causes of Alzheimer’s disease.
Karolina Wojtunik-Kulesza
exaly +5 more sources
A Bayesian perspective on Biogen's aducanumab trial [PDF]
AbstractThis perspective is a companion to a recent editorial on the use of Bayesian analysis in clinical research. We aim to introduce and highlight the relevance and advantages that Bayesian inference offers to clinical trials using the data on the amyloid antibody aducanumab presented at a Food and Drug Administration hearing in November 2020 as an ...
Michael Lutz, Stefan Teipel, Yi Tang
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Aducanumab in Alzheimer’s Disease: A Critical Update
: Alzheimer's disease (AD) is a complex neurological disorder that results in cognitive decline. The incidence rates of AD have been increasing, particularly among individuals 60 years of age or older. In June 2021, the US FDA approved aducanumab, the first humanized monoclonal antibody, as a potential therapeutic option for AD.
Shubneesh Kumar
exaly +4 more sources
Aducanumab and the certainty of evidence [PDF]
No abstract available.
Terence J Quinn, Jenny McCleery
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Aducanumab for Alzheimer’s disease: A regulatory perspective
On June 7th 2021, the Food and Drug Administration (FDA) granted approval for Aduhelm (aducanumab) for the treatment of Alzheimer's disease under its accelerated approval program. Aducanumab is the first putative disease-modifying therapy (DMT) approved for the treatment of AD with a great potential for clinical benefit over current symptomatic ...
John-Joseph Borg, Robert Nistico
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Aducanumab anti-amyloid immunotherapy induces sustained microglial and immune alterations [PDF]
Aducanumab, an anti-amyloid immunotherapy for Alzheimer\u27s disease, efficiently reduces Aβ, though its plaque clearance mechanisms, long-term effects, and effects of discontinuation are not fully understood.
David Holtzman, Kimberly Olney
exaly +2 more sources
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Revisiting FDA Approval of Aducanumab
New England Journal of Medicine, 2021Revisiting FDA Approval of Aducanumab Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, it’s essential to consider b...
G Caleb, Alexander +6 more
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