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FDA rejects approval for Alzheimer's drug

Eli Lilly and Co. reported on January 19, 2023 that the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug, donanemab, because it had not submitted enough trial data from patients who were treated for at least a year. The drug, an antibody, was designed to remove amyloid protein plaques from the brains of people with early stage Alzheimer's dementia. The FDA did so due to the limited number of patients with at least 12 months of drug exposure data provided in the submission. Apparently the drug appeared to clear amyloid in 40% of trial participants after six months of treatment and caused them to drop out. The rejection - actually a deferral awaiting more clinical data from over a longer period - will lead Eli Lilly to continue conducting clinical trials and revamp its study design. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Full approval requires clinical evidence a drug will help patient outcomes.

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