If granted full FDA approval, which could come in early July, treatment could boost annual Medicare spending by nearly $9 billion, analysis shows.
Advisers to the U.S. Food and Drug Administration on Friday voted unanimously in favor of the Eisai Co. Ltd. and Biogen Alzheimer’s treatment Leqembi, saying that a clinical study had verified its benefit.
Eisai ESALF shares jumped on the news and finished the day up 9.4%. Biogen BIIB stock trading was halted Friday during the advisory committee meeting. About 6.7 million people 65 and older in the U.S. are living with Alzheimer’s dementia, according to the Alzheimer’s Association. Alzheimer’s was the fifth-leading cause of death among people 65 and older in 2019, according to the association.
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Eisai-Biogen Alzheimer's Drug Data Confirms Benefits: FDAUS Food and Drug Administration staff on Wednesday said data from a late-stage trial of Eisai and Biogen's Alzheimer's disease drug suggests it offered a meaningful benefit to patients.
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FDA panel weighs US approval for Alzheimer's drug from Eisai and BiogenA panel of expert advisers on Friday began their meeting to discuss whether to recommend traditional U.S. regulatory approval for Eisai and Biogen's new Alzheimer's drug Leqembi, a move expected to expand Medicare payment for the treatment.
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Alzheimer’s advocates rally for Medicare coverage of newly approved FDA treatmentsNew treatments for Alzheimer’s are on the market, but the price tag is making them inaccessible. The new treatments are not covered by Medicare or Medicaid, which is something the Alzheimer’s Association is trying to change.
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FDA advisers vote that lecanemab shows benefit as an Alzheimer’s treatment | CNNAn advisory panel for the US Food and Drug Administration voted unanimously Friday that the Alzheimer’s drug lecanemab shows “clinical benefit” for the treatment of the disease, paving the way for the medication to be considered for full FDA approval, which is expected by July 6.
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Alzheimer's drug Leqembi gets FDA panel's backing, setting the stage for broader useU.S. health advisers are backing the full approval of an Alzheimer's drug that received preliminary approval last year.
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Alzheimer’s drug gets FDA panel’s backing, setting the stage for broader useHealth advisers on Friday unanimously backed the full approval of a closely watched Alzheimer’s drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease.
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