Prescribing Aducanumab in the Face of Meager Efficacy and Real Risks

David S. Knopman; Joel S. Perlmutter

doi:10.1212/WNL.0000000000012452

Prescribing Aducanumab in the Face of Meager Efficacy and Real Risks

David S. Knopman, Joel S. Perlmutter

Neurology

Research output: Contribution to journal › Review article › peer-review

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 (US)
Pages (from-to)	545-547
Number of pages	3
Journal	Neurology
Volume	97
Issue number	11
DOIs	https://doi.org/10.1212/WNL.0000000000012452
State	Published - Sep 14 2021

ASJC Scopus subject areas

Clinical Neurology

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10.1212/WNL.0000000000012452

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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.",

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AB - 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.

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Prescribing Aducanumab in the Face of Meager Efficacy and Real Risks

Abstract

ASJC Scopus subject areas

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