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Regulation

FDA’s rationale for amyloid surrogate endpoint sure to spark controversy

Aducanumab review documents fail to provide clear explanation of agency’s embrace of amyloid hypothesis

Aducanumab review documents fail to provide clear explanation of agency’s embrace of amyloid hypothesis.

Jun 23, 2021 | 3:22 AM GMT

Documents released by FDA summarizing its review of Biogen’s aducanumab do little to settle the dispute over the drug’s efficacy, rehashing rather than resolving the litany of arguments on either side. While the documents provide insight into what convinced the agency that amyloid clearance is an appropriate surrogate endpoint for Alzheimer’s disease, they introduce logic jumps that will stoke rather than quell debate. 

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