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July 28, 2021New England Journal of Medicine164 citationsOpen Access

Revisiting FDA Approval of Aducanumab

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GAG. Caleb AlexanderDKDavid S. KnopmanSEScott S. Emerson

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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.

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Alexander et al. (2021) studied this question.

synapsesocial.com/papers/6a202fc8f8c30f43cdfc002fhttps://doi.org/10.1056/nejmp2110468
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