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FDA Approves use of Leqembi for Alzheimer's

Updated: Jan 10

On January 6, 2023, the Food and Drug Administration approved the use of an Alzheimer's drug, Leqembi (lecanemab), manufactured by Eisai (and Biogen), that is reported to modestly slow the pace of cognitive decline early in the disease, but also carries risks of swelling and bleeding in the brain. Studies of the drug — an intravenous infusion administered every two weeks — suggest it may be more promising than other treatments available. However, Alzheimer’s experts have noted that it was unclear from the medical evidence whether Leqembi could slow cognitive decline enough to be noticeable to patients. The list price for the drug is $26,500 per year. The FDA's label for the drug cautions the drug should be used only for patients in early and mild stages of Alzheimer’s disease (similar to that of patients in the clinical trials of the drug). The label also instructs doctors not to treat patients without doing tests to confirm that they have one of the hallmarks of Alzheimer’s -- a buildup of the protein amyloid -- which the drug is designed to decrease. While Eisai/Biogen included a broader representation of the general population in its trials, still adults with neuroatypical conditions, such as intellectual disability, were excluded. For more information related to Down syndrome, see the 'Statement' of the Lumind IDSC Foundation. For a deeper read on the scientific basis for the use of Leqembi, see the story from CNN or the story in the New York Times.


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