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☆ Second Alzheimer’s drug to slow disease’s progression may be approved in the US this year
▼ + stars: | 2023-07-17 | by ( Meg Tirrell | ) edition.cnn.com time to read: +12 min

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, “

☆ Sales of Alzheimer’s drug Leqembi may be slow initially but could pick up in 2024
▼ + stars: | 2023-07-07 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

Sales of the Alzheimer's drug Leqembi may be slow initially due to logistical requirements but could pick up in 2024, analysts said after the groundbreaking treatment won approval in the U.S.Wall Street is chewing over the Food and Drug Administration's Thursday approval of Leqembi – a milestone in the treatment of the disease, even though the drug isn't a cure. Leqembi, from drugmakers Eisai and Biogen , is the first medicine proven to slow the progression of Alzheimer's in people at the early stages of the memory-robbing disease. Yee added that the firm's channel checks suggest doctors see the registry requirement "as a potential real-world challenge – at least in the initial phase." That includes navigating Medicare's registry requirement and coordinating PET scans and MRIs to screen for dangerous side effects of the drug. But Goodman, like other analysts, also noted that "we continue to expect a slow ramp in 2023 and acceleration moving into 2024."

Persons: Jay Reinstein, drugmakers, Yatin Suneja, Jefferies, Michael Yee, Yee, Paul Matteis, Marc Goodman, Goodman Organizations: Georgetown University Hospital, Wall, Food, Leqembi, FDA, National Institute, Aging, ARIA, SVB Securities Locations: Washington , DC, U.S

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

☆ Bernie Sanders says price of Alzheimer's treatment is unconscionable, calls on HHS to take action
▼ + stars: | 2023-06-07 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

Sen. Bernie Sanders on Wednesday called on the U.S. Health and Human Services Department to take action to ensure seniors can actually afford the expensive Alzheimer's treatment Leqembi. Sanders, who chairs the Senate Health Committee, in a letter to HHS Secretary Xavier Becerra called the $26,500 annual price tag for Leqembi set by drugmakers Eisai and Biogen "unconscionable." Sanders said the "outrageously high price" of Leqembi "will prevent seniors who need this drug from receiving treatment." Most Medicare patients suffering from Alzheimer's would not be able to afford the 20% co-payment of more than $5,000 a year for Leqembi, Sanders said. Co-payments, along with coinsurance and deductibles, are medication and health services costs that patients must personally pay for out of pocket, as opposed to being covered by their health insurance.

Persons: Sen, Bernie Sanders, Sanders, Xavier Becerra, drugmakers Eisai, Becerra, Mr Organizations: U.S, Capitol, U.S . Health, Human Services Department, Health, Medicare, HHS, Services, Leqembi, Democratic, Senate, Clinical Locations: Washington , DC, Vermont

A newly approved drug intended to slow the progression of Alzheimer’s disease offers patients hope, but it will come with a steep price tag: $26,500 a year. That drug initially cost $56,000 per year before Biogen slashed the price in half, to $28,000 annually. Dr. David Rind, the institute's chief medical officer, said an appropriate cost for the drug is $8,500 to $20,600 a year. John Domeck, 60, of Aurora, Ohio is currently enrolled in a phase 3 clinical trial testing Leqembi. But right now, the clinical trial for Leqembi shows that the drug provides "modest efficacy at a big, big price," Caplan said.

The Food and Drug Administration on Friday approved an Alzheimer’s drug shown in clinical trials to slow cognitive decline in patients in the early stages of the illness. The FDA approved Leqembi for use in people with mild cognitive impairment or early Alzheimer’s disease. Most drugs approved by the FDA for Alzheimer’s are aimed at helping symptoms, not actually slowing the progression of the disease. Friday's announcement comes on the heels of a scathing congressional report released last week detailing the approval of a different Alzheimer’s drug, called Aduhelm. The Alzheimer's Association has said that based on the Eisai and Biogen phase 3 clinical trial results, the FDA should approve Leqembi for early-stage Alzheimer’s.

☆ Rare success for Alzheimer's research unlocks hope for future therapies
▼ + stars: | 2022-11-29 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +6 min

Eisai and Biogen are scheduled to present full data from their lecanemab study on Tuesday at the Clinical Trials on Alzheimer's Disease conference in San Francisco. Lecanemab’s success rests on years of research into the causes of Alzheimer’s as well as advances in measuring amyloid deposits through brain scans and spinal fluids. At least 16 treatments are being tested in clinical trials, with results expected over the next three years, according to a Reuters review of the clinicaltrials.gov registry. The drugmaker has been largely absent from the Alzheimer's space after the high-profile failure of its drug verubecestat five years ago. But several antibody therapies from Lilly, Biogen and AbbVie(ABBV.N) that were designed to slow the rate of tau accumulations failed outright last year.

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