FDA reviewers ask if approval of Lilly’s Alzheimer’s drug should be restricted to a smaller group

Scientists at the Food and Drug Administration have two big questions about Eli Lilly’s experimental Alzheimer’s drug donanemab ahead of a panel of outside experts that it is convening on Monday:

Should the patients who receive the medicine be limited based on PET scans of a protein called tau that Eli Lilly used as a key criteria for trying to determine whether they should receive the drug? That could reduce usage of the medicine by adding a barrier to its use.

And how do the potential risks of using the drug compare to its benefits? The FDA points to one analysis, admittedly with missing data, that could indicate patients who receive the drug have a higher risk of dying.

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