Prescribing Aducanumab in the Face of Meager Efficacy and Real Risks

The US Food and Drug Administration (FDA) approved aducanumab on June 7, 2021, using an accelerated approval mechanism, based on evidence that aducanumab reduced brain β-amyloid (Aβ) peptide.1 The FDA press release stated that the effect on the surrogate end point "is reasonably likely to predict a clinical benefit to patients."at some point in the future. As clinical neurologists, we should understand the evidence for this approval and whether this justifies prescribing this medication. © 2021 American Academy of Neurology.