FDA advisers will review an antibody from Eli Lilly that's been held up by safety and efficacy concerns.
will come into focus Monday, when Food and Drug Administration advisers review an application from Eli Lilly that's been held up by questions about the design of clinical trials and safety risks.Their conclusions could influence how the FDA treats future drugs that target proteins in the brain known as amyloid plaques that are believed to contribute to the development of the dreaded neurological condition that afflicts nearly 7 million people in the U.S.
It questions whether measured tau levels should be used to limit which patients get the drug, which would shrink the potential market for the treatment.there were 17 deaths in patients given donanemab, compared with 10 who received placebo. They said risks could be described in the prescribing information, including a boxed warning, similar to the one for Leqembi.
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