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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. 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. Both Leqembi and donanemab work by clearing buildups of a protein in the brain called amyloid, a hallmark of Alzheimer’s. It’s been a hypothesis that treating Alzheimer’s earlier with amyloid-clearing drugs would yield better results; Skovronsky said the donanemab trial bore that out. “We could look at people who had mild cognitive impairment, MCI, which is the earliest stage, versus mild Alzheimer’s versus moderate Alzheimer’s,” Skovronsky explained.
Persons: Leqembi, Eli Lilly’s donanemab, Lilly, “ Donanemab, Jennifer Manly, Kacie, , Dr, Gil Rabinovici, Renaud La Joie, Daniel Skovronsky, , Skovronsky, ” Skovronsky, It’s, Eric Widera, Sharon Brangman, University of Wisconsin’s Dr, Nathaniel Chin, Donanemab, Lilly hasn’t, Lawrence Honig, Honig, White, Sanjay Gupta, Deters, ” Lilly, it’s “, it’s, there’s, Joe Montminy Organizations: CNN, Alzheimer’s Association, Food and Drug Administration, American Medical Association, Columbia University Irving Medical Center, University of California, MCI, SUNY, University of Wisconsin’s, Leqembi, FDA, donanemab, CNN Health, ” Manly Locations: Los Angeles,
CNN —The US Food and Drug Administration is expected to decide on Thursday whether to grant traditional approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease. Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with Alzheimer’s through Medicare, the drug hasn’t been widely used. People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks. Broad Medicare coverage of Leqembi and similar types of medications to slow the progression of Alzheimer’s disease would probably have a big impact on the program’s spending.
Persons: drugmakers, hasn’t, , ’ ”, Joe Montminy, Lawrence Honig, “ It’s, , Honig, it’s, Leqembi, ” Honig, Georges Naasan, Sue Rottura, ” Drugmaker Eisai, “ You’re, Ivan Cheung, Eisai, ” Montminy, Dr, Sanjay Gupta Organizations: CNN, Food and Drug Administration, Medicare, Services, CMS, Columbia University Irving Medical Center, Alzheimer’s, Behavioral, CNN Health, Kaiser Family Foundation Locations: Mount, Florida
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