'Biased and misleading': No holds barred in FDA's statistical review of Biogen's Aduhelm
New FDA review documents from the Aduhelm decision released Monday make clear why the agency’s own statisticians dissented on the controversial accelerated approval.
At the center of the accelerated approval, according to the nearly 400-page clinical review, is two large, international pivotal trials (Studies 301 and 302) that were nearing completion but were terminated prior to their planned conclusion. Modeling and simulation allowed the FDA and Biogen to complete those two trials, which established that their results were interpretable and suitable for additional consideration. Whereas the positive Study 302 “provides the primary evidence of effectiveness” for the approval, Study 301 failed.
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