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Second Alzheimer's drug to slow disease's progression may be approved in the US this year

The full You do not have permission to view the full content of this post. Log in or register now.this month of the Alzheimer’s drug Leqembi marked a historic shift in the treatment of the disease: For the first time, doctors have a medicine to prescribe that has been proven to slow the loss of memory and ability to do daily tasks that Alzheimer’s brings.

A second drug may join Leqembi — known as lecanemab before it got its brand name — on the market by the end of the year: Eli Lilly’s donanemab.

It was shown in May and in fuller Phase 3 clinical trial results released at the Alzheimer’s Association International Conference on Monday to delay the disease’s progression. Lilly said in a news release that it had completed its US Food and Drug Administration submission for the drug, and expects regulatory action by year’s end.

More than 6 million Americans are estimated to have Alzheimer’s disease, with about 1 million estimated to be in the early symptomatic stages where these drugs have shown benefit. But even though the medicines are the first to put a brake on the seemingly inexorable progression of Alzheimer’s, experts questioned the degree of their benefit in a series of editorials published Monday in the Journal of the American Medical Association, alongside the donanemab data.

Both Leqembi and donanemab work by clearing buildups of a protein in the brain called amyloid, a hallmark of Alzheimer’s.

“Donanemab was very effective at eliminating its target, cerebral amyloid, but the clinical effect was comparatively weak,” Jennifer Manly, of Columbia University Irving Medical Center, and Kacie Deters, of the University of California, Los Angeles, wrote in one editorial.

Patients taking the medicine in the more than 1,700-person trial had 35% slower progression of disease than those on placebo over a year and a half on a measure called the integrated Alzheimer’s Disease Rating Scale, or iADRS, the results showed. That equated to a loss of six points on a 144-point scale for those on the drug, compared with a loss of nine points for those on placebo.

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Source: CNN
 

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