Alzheimer's adcomm members question FDA: How can you use amyloid as the basis for an accelerated approval?
The FDA has not yet provided a persuasive scientific basis for declaring beta-amyloid as a reasonable surrogate for an accelerated approval, seven members of the adcomm that reviewed aducanumab and unanimously voted against its approval, wrote Wednesday in the New England Journal of Medicine.
Although the FDA has released key reviews on the internal dissent around the agency’s decision to OK Biogen’s new controversial Alzheimer’s drug, the experts (three of whom have since resigned from the adcomm in protest over the approval) explained how more than two dozen therapies based on this amyloid hypothesis have undergone late-stage clinical trials, and none have shown meaningful clinical benefit.
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