Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility

This viewpoint details the development and regulatory path of aducanumab, a human IgG1 monoclonal antibody, including termination of 2 clinical trials, identification of conflicting evidence of efficacy, and FDA advisory committee vote against approval (final decision pending).

Journal of the American Medical Association