Aducanumab: First Approval

online resource

posted on 2021-08-11, 03:35 authored by Sohita Dhillon

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Sohita Dhillon is a contracted employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Aducanumab (aducanumab-avwa; Aduhelm™) is a human, immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid β. It has been developed by Biogen under license from Neurimmune for the treatment of Alzheimer's disease. Alzheimer’s disease is characterised by the accumulation of extracellular amyloid β as neuritic plaques and congophilic angiopathy, as well as the intracellular accumulation of abnormally phosphorylated tau in the form of neurofibrillary tangles. Aducanumab reduces amyloid β plaque levels in a dose- and time-dependent manner. In June 2021, aducanumab received its first approval in the US for the treatment of Alzheimer’s disease. Aducanumab is under regulatory review in Japan and in Europe. Its long-term safety and tolerability is being evaluated in a multinational phase 3 clinical study in patients with early Alzheimer’s disease (mild cognitive impairment and mild Alzheimer’s disease). This article summarizes the milestones in the development of aducanumab leading to this first approval for Alzheimer’s disease.