Abstract
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.
Original language | English |
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Pages (from-to) | 545-547 |
Number of pages | 3 |
Journal | Neurology |
Volume | 97 |
Issue number | 11 |
DOIs | |
State | Published - Sep 14 2021 |