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Comment by Majromax

Derek Lowe has a recent article on the subject (https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th...) that covers the issue in some detail by way of criticism.

In short, the medication does appear to reduce the beta-amyloid plaque buildup in the brains of patients with Alzheimer's. However, in the phase 3 study that plaque reduction did not appear to result in any clinical improvement in patients. The Phase 3 trial was "stopped for futility."

That's why the advisory panel could recommend rejection -- the drug did not appear to help patients. But equivalently, it did do the thing it set out to do, so that justified (ish?) the final approval.

parent Majromax 5 years ago

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