Aducanumab: First Approval

Aducanumab (aducanumab-avwa; Aduhelm (TM)) is a human, immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. It has been co-developed by Biogen and Eisai under license from Neurimmune for the treatment of Alzheimer's disease. In June 2021, aducanumab received its first approval in the USA for the treatment of Alzheimer's disease. According to the US FDA prescribing information, treatment should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. Aducanumab is under regulatory review in Japan and in Europe. Its long-term safety and tolerability is being evaluated in a multinational phase 3b 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.

Automated summary

Aducanumab is a monoclonal antibody developed for the treatment of Alzheimer's disease, targeting aggregated forms of amyloid beta. It has received approval in the USA for use in patients with mild cognitive impairment or mild dementia. Ongoing studies are evaluating its safety and efficacy in patients with early Alzheimer's disease.