Revisiting FDA Approval of Aducanumab
G. Caleb Alexander, David S. Knopman, Scott S. Emerson, Bruce Ovbiagele, Richard J. Kryscio, Joel S. Perlmutter, Aaron S. Kesselheim
Abstract
Interview with Dr. Gil Rabinovici on the FDA’s controversial approval of a new treatment for Alzheimer’s disease. (16:39)Download Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, it’s essential to consider beta-amyloid’s suitability as a surrogate end point. Doing so casts doubt on the wisdom of the decision.
Topics & Concepts
DownloadDrug approvalDiseaseMedicinePsychologyPsychiatryPathologyComputer scienceDrugWorld Wide WebAlzheimer's disease research and treatmentsCholinesterase and Neurodegenerative DiseasesHealth Systems, Economic Evaluations, Quality of Life