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New Alzheimer’s Drug Approval Delayed by FDA

In a decision that surprised many who keep tabs on developments in Alzheimer’s drugs, the Food and Drug Administration (FDA) has delayed action on the drug donanemab and is requiring that the drug get additional scrutiny by a panel of independent experts. The drug’s maker, Eli Lilly and Company, was quoted as saying, “The FDA wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design.” This is expected to delay a final decision until at least later in 2024. Last year, the FDA approved another Alzheimer’s drug, Leqembi (lecanemab), made by Eisai and Biogen, which has been shown to modestly slow cognitive decline in the early stages of Alzheimer’s. The trial design for donanemab had been different in that it included some patients with more complex medical problems. There were also two other unique aspects to the trial — one being that some participants stopped receiving donanemab to see if their cognitive decline would still keep slowing, which it did. The FDA wants to know more about this stopping-treatment approach. A second unique feature of the trial involved another protein, tau, which forms tangles in the brain after amyloid accumulates. Higher tau levels are more closely associated with memory and thinking problems. The trial divided participants into groups with high tau levels and intermediate tau levels and found that people with intermediate tau levels had more slowing of cognitive decline. This supports the theory that treating patients as early as possible in the disease process provides a better chance of slowing symptoms. (The first drug approved in the anti-amyloid class, Aduhelm (aducanumab), has been pulled from the market by its maker, Biogen, due in part to questions about its effectiveness and safety and an approval process that proved to be controversial.) For more on the status of Alzheimer’s drugs, see our AgeWise Colorado articles at https://agewisecolorado.org/blog/alzheimers-drugs-are-works-in-progress/ and https://agewisecolorado.org/blog/colorado-physicians-weigh-in-on-alzheimers-drug-leqembi/ and https://agewisecolorado.org/blog/one-alzheimers-drug-being-pulled-new-one-being-tested/.

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