Alzheimer ’s & Dementia researchers challenge FDA ’s approval of Aduhelm given lack of evidence for beta-amyloid as a marker

Doctors Blast Biogen Alzheimer Approval as ‘Regulatory Failure’ (Bloomberg): Top researchers who advised the U.S. Food and Drug Administration on Biogen Inc.’s Alzheimer’s drug blasted the agency for approving it, calling the decision a “regulatory failure” that is “at odds with the evidence.” The New England Journal of Medicine opinion piece, signed by seven members of an advisory panel that opposed clearing Biogen’s Aduhelm, is another sign of persistent furor over the agency’s decision … The new commentary is signed by them and four other panel members, including doctors from Harvard Medical School, the Mayo Clinic, and the University of California, San Francisco. An investigation of Aduhelm’s approval “should be expeditiously performed, so as to learn how this regulatory failure occurred and to ensure that it doesn’t occur again,” the researchers wrote. The Statement: Revisiting FDA Approval of Aducanumab (oped at The New England Journal of Medicine) The committee was never consulted about beta-amyloid’s suitability as a surrogate. Indeed, the lead FDA scientist told us, “We’re not using the amyloid as a surrogate for efficacy.” Moreover, the data did not support this use. An effective surrogate should strongly correlate with a clinical end point in clinical studies, but an FDA statistical review of Studies 301 and 302 found no evidence that amyloid changes correlated with cognitive or functional changes, concluding that “it is not ...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health Aduhelm Alzheimer's drug Alzheimers-treatment beta-amyloid Biogen cognitive FDA approval surrogate Source Type: blogs