On 7 June the FDA approved aducanumab, the first new drug for Alzheimer's disease in almost 20 years-and notably, the first drug with a putative disease-modifying mechanism for the treatment of this devastating disorder, namely the removal of β-amyloid (or Aβ) plaques from the brain.
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Alzheimer's disease (AD) is a complex/multifactorial brain disorder involving hundreds of defective genes, epigenetic aberrations, cerebrovascular alterations, and environmental risk factors. The onset of the neurodegenerative process is triggered decades before the first symptoms appear, probably due to a combination of genomic and epigenetic phenomena. Therefore, the primary objective of any effective treatment is to intercept the disease process in its presymptomatic phases.
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[Anti-Amyloid Antibody Therapy for Alzheimer's Disease].
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Article Synopsis
- Alzheimer's disease is marked by the buildup of amyloid plaques and neurofibrillary tangles, leading to neuronal death and various forms of protein aggregation related to toxicity.
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Yasuo Toda, Biogen Japan Ltd., 1-4-1 Nihonbashi, Chuo-ku, Tokyo 103-0027, Email: Phone: +81-3-3275-2074, Fax: +81-3-3275-1920, ORCID: 0000-0002-8737-5256.
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- The global incidence of dementia, particularly Alzheimer's disease (AD), is increasing, prompting the need for effective treatments like aducanumab, which targets amyloid beta involved in AD.
- Aducanumab was approved by the FDA in June 2021 for treating early AD through an accelerated approval process, supported by data from two global phase 3 studies, EMERGE and ENGAGE.
- In these studies, Japanese participants with a confirmed diagnosis of mild cognitive impairment or mild AD dementia were evaluated for the drug's efficacy, safety, and pharmacokinetics, with results aligning closely with the overall findings.
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