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Relitigating Aduhelm: CDER’s Cavazzoni Uses Leqembi Approval To Defend Aducanumab Decision

Executive Summary

Although Aduhelm’s accelerated approval in June 2021 ‘generated a significant amount of discussion among external stakeholders,’ CDER’s work on that application ‘led to a leap in our understanding of amyloid as a surrogate marker and a greater understanding of the role that a reduction in amyloid plaque may play in a slowing of the disease,’ drug center director says.

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