FDA Approves Early Treatment Alzheimer's Drug

Drug to be sold as Lequembi has safety concerns, however
By Evann Gastaldo,  Newser Staff
Posted Nov 30, 2022 2:16 AM CST
Updated Jan 6, 2023 2:21 PM CST
This Could Be a 'Momentous, Historic' Moment in Fight Against Alzheimer's
This illustration made available by the National Institute on Aging/National Institutes of Health depicts cells in an Alzheimer’s affected brain, with abnormal levels of the beta-amyloid protein clumping together to form plaques, brown, that collect between neurons and disrupt cell function.   (National Institute on Aging, NIH via AP)
UPDATE Jan 6, 2023 2:21 PM CST

A drug found to slow the progression of Alzheimer's disease received federal approval on Friday for patients dealing with mild impairment. Lecanemab was effective in clinical trials but raised safety concerns, and experts say the benefits are not overwhelming, NBC News reports. Nevertheless, the FDA fast-tracked its approval, not consulting its advisory committee. The yearly price of the drug, which will be sold under the name Leqembi, is estimated at about $9,000 to $35,605, and insurance coverage will be limited, at least at first. Many experts consider the drug an important step that will keep people from reaching severe impairment longer.

Nov 30, 2022 2:16 AM CST

A new Alzheimer's drug is being hailed as potentially "momentous and historic," though with some potentially serious caveats as well. A study found that the drug, lecanemab, which had already yielded promising results in an initial trial, can slow the progression of cognitive decline in people with Alzheimer's—the first time a drug has been found to do that, the BBC reports. Scientists were effusive in their reactions to the research, Sky News reports. "At long last we have gained some traction on this most terrible and feared disease and the years of research and investment have finally paid off," says one professor. "It feels momentous and historic." However, the Washington Post reports, researchers were also warning that the drug was found to be associated with some "adverse events" and that the safety risks need to be studied further.

Two deaths of patients involved in the study raised concerns, but, as a study co-author explains, causality was difficult to determine and both patients had underlying health problems. The makers of the drug, Tokyo-based Eisai and Massachusetts-based Biogen, denied the deaths had anything to do with the medication. The co-author adds that the study also found a low rate of brain bleeding in patients who took the drug, but that the risk goes up if taken with medications to prevent blood clotting, so that issue might need to be "managed." As for the study results, it found that patients on lecanemab, which targets amyloid beta, a protein in the brain suspected to play a role in Alzheimer's, showed less decline on cognitive measures at 18 months than those who took a placebo, CNN reports. USA Today calls the benefit "moderate." (Read more lecanemab stories.)

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