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An experimental Alzheimer’s drug developed by Eisai Co., Ltd. and Biogen slowed cognitive and functional decline in large clinical trials in patients in the early stages of the disease, they said Tuesday. rice field.
Several pharmaceutical companies have tried, unsuccessfully, to find effective treatments for the brain-wasting disease that affects about 55 million people worldwide. The breakthrough would be a big boost to similar research being conducted by Roche and Eli Lilly.
“It’s not a huge effect, but it’s a positive effect,” said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center in Rochester, Minnesota, of the Eisai Biogen drug results announced late Tuesday night. I’m here.
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The drug lecanemab slowed disease progression by 27% compared to placebo, potentially meeting the primary goal of the study and offering hope to patients and their families desperate for an effective treatment.
The race to halt the progression of Alzheimer’s disease is expected to nearly double to 13 million Americans by 2050, according to the Alzheimer’s Association.
Alzheimer’s International says it could reach 139 million people worldwide by 2050 without an effective treatment.
Eisai, the leader of the 50-50 Partnership’s lecanemab program, is seeking FDA approval under an expedited pathway, with a decision expected in early January.
The company aims to have full approval and commercialization in the US, Europe and Japan by the end of 2023, CEO Haruo Naito told reporters in Tokyo.
After failing to trade on Wednesday with a large number of buy orders, Eisai’s shares rose 17% to close at a daily limit of 1,000 yen, according to Tokyo Stock Exchange rules, indicating further strong buying demand on Thursday. I’m here. Biogen shares surged 50% in premarket trading, boosting shares in rivals Roche and Eli Lilly.
Eisai said the results of a trial of 1,800 patients showed that removing sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s disease could slow the progression of the debilitating disease. He said he proved a long-standing theory.
The data is a “clear win” for Alzheimer’s patients, says BMO analyst Evan Seigerman, and Jefferies analyst Michael Yee suggests new multi-billion dollar franchise potential said it does.
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“Very Early Days”
Lecanemab, like its partner’s previous drug Aduhelm, is an intravenous antibody designed to clear amyloid deposits. Unlike Aduhelm, lecanemab targets the unaggregated form of amyloid.
“If you can slow the progression of the disease by almost 30%, that’s great,” said Jeff Cummings, Ph.D., director of the Chambers Grundy Center for Transformational Neuroscience at the University of Nevada, Las Vegas.
The so-called amyloid hypothesis has been challenged by some scientists, especially after the U.S. Food and Drug Administration’s controversial 2021 approval of Aduhelm’s ability to clear plaque rather than evidence of slowing cognitive decline. was based on The decision came after the FDA’s own panel of outside experts advised against approval.
Dr. Christian Steen Frederiksen, director of the Clinical Trials Unit at the University of Copenhagen, said that while lecanemab’s top-line results are compelling, it remains to be determined whether the effect is clinically meaningful. It’s a very early time.”
Alzheimer’s disease is “a very complex disease, and it is unlikely that amyloid-related pathology is the sole factor,” he said. less likely to be.”
Aduhelm was the first new Alzheimer’s drug approved in 20 years after a long list of high-profile failures in the industry.
Patient advocacy groups welcomed the news of positive trial results for lecanemab.
“We hope the FDA will approve this drug in January,” said George Vradenburg, president of USAagainstAlzheimer.
A phase III trial evaluated the drug’s ability to reduce cognitive and functional decline based on the Clinical Dementia Rating Box Sum (CDR-SB). Judgment, problem solving and personal care.
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swelling of the brain
The rate of side effects of brain swelling associated with anti-amyloid therapy was 12.5% in the lecanemab group compared to 1.7% in the placebo group. However, many cases did not cause symptoms, and 2.8% of him in the lecanemab group had symptomatic brain swelling, the company said.
Microbleeds in the brain occurred in 17% of patients in the lecanemab group and 8.7% in the placebo group.
Petersen says the incidence of side effects is much lower than with Aduhelm and is “certainly acceptable.”
Aduhelm’s approval was a rare bright spot for Alzheimer’s patients, but critics want more evidence that amyloid-targeting drugs are worth the cost.
Controversy and hesitation over Aduhelm’s compensation by some payers prompted Biogen to cut the drug’s price from an original $56,000 to $28,000 annually.
Medicare, the U.S. government’s health insurance for people 65 and older, said this year it would pay for Aduhelm and other similar drugs only if patients were enrolled in valid clinical trials. This has greatly reduced the use of drugs.
Eisai’s deputy chief clinical officer, Michael Irizary, said on a conference call that the company would hold discussions. Medicare and Regarding coverage of lecanemab.