The FDA embraces the use of biomarkers and surrogate endpoints in its most recent guidance on developing therapeutics for early Alzheimer’s disease.
The US Food and Drug Administration embraced the use of biomarkers and surrogate endpoints in its most recent guidance on developing therapeutics for earlyis the first update since 2018 for products aimed at the earliest stages of the disease, which the FDA defines as stages 1, 2, and 3.
In 2018, the FDA suggested that biomarker evidence of disease might only play a role in identifying trial participants but should not be a defining element. "The FDA has determined there is substantial evidence that reduction of amyloid beta plaques in the brain is reasonably likely to predict important clinical benefits to patients," said Edelmayer, adding the agency's "determination is correct."
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