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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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US FDA Sees Leqembi Data As Vindicating Its Approach To Alzheimer’s Drugs

Two-and-a-half years after Aduhelm’s tumultuous advisory committee, FDA finally gets positive vote it was looking for, albeit on a different product. Leqembi meeting serves to endorse CDR-SB as clinical endpoint as well as amyloid plaque as surrogate for reduction in decline.

US FDA Neuroscience Office Director Billy Dunn Departs As Agency Faces New Review Challenges

Dunn is retiring after an 18-year career that included involvement in some high-profile and controversial drug approval decisions, not the least of which is Biogen’s Alzheimer’s treatment Aduhelm; deputy director Teresa Buracchio takes over the neurology office on an acting basis.

The Conflicting Lessons Of Aduhelm

US FDA is understandably feeling vindicated about the decision to use beta amyloid as a surrogate marker in Alzheimer’s. But the agency needs to be careful because critics of its landmark accelerated approval decision for Aduhelm are not arguing about the science.

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