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

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. 

The data package supporting the accelerated approval of Aduhelm aducanumab from  Biogen Inc. (NASDAQ:BIIB) was uncommonly complex, involving a large number of post hoc analyses open to different conclusions. ...