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As Aducanumab’s US FDA Review Progressed, Support Grew For Accelerated Approval

Executive Summary

Use of expedited pathway for Biogen's Alzheimer's drug was discussed at a center director briefing in late April, where it garnered backing from several senior CDER officials, as well as CBER director Peter Marks and OCE director Richard Pazdur.

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Alzheimer’s And Surrogate Endpoints: FDA’s On A Case-By-Case Basis Per New Guidance

After Aduhelm and Leqembi rendered the 2018 guidance moot, FDA formally acknowledges the possibility of using surrogate endpoints for accelerated approval in Alzheimer’s in updated draft but says acceptability of the any endpoint will depend on details of specific therapeutic program.

After Leqembi Approval, US FDA In No Rush To Declare Amyloid A Validated Surrogate Endpoint

Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.

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

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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