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[ad_1] Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.'s shares climbed in early US trading after its experimental drug for Alzheimer's slowed the progress of the disease in a final-stage trial, paving the way for the company to apply for US approval. AJ Mast | Bloomberg | Getty Images Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move. The agency plans to call a last-minute meeting of its outside advisors to further review the treatment's safety and efficacy in a late-stage trial, Eli Lilly said. The FDA has not disclosed the date of that meeting, so a potential approval would likely come after this month. The FDA was expected to decide whether to greenlight the medicine by the end of the first quarter. That deadline was already delayed from an expected approval last ye

[ad_1] Sen. Bernie Sanders (I-VT) arrives to the U.S. Capitol Building on June 01, 2023 in Washington, DC. Anna Moneymaker | Getty Images 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." The Vermont independent said the drug's current cost would put a substantial financial burden on Medicare and increase premiums for seniors. Medicare is the federal program that provides health coverage to primarily older Americans. Sanders said the "outrageously high price" of Leqembi "will prevent seniors who need this drug from receiving treatment." The lawmaker wrote that HHS should use its authority to break Leqembi's pa

[ad_1] The Alzheimer's drug Leqembi is seen in this undated handout image obtained by Reuters on Jan. 20, 2023. Eisai | Reuters The new Alzheimer 's antibody treatment Leqembi could cost Medicare up to $5 billion per year, according to research published in a leading medical journal this week. Medicare would spend about $2 billion per year if around 85,700 patients test positive for the disease and are treated with the Eisai and Biogen product Leqembi, according to the research published Thursday in JAMA Internal Medicine. The program for seniors would spend $5 billion if around 216,500 patients become eligible for the breakthrough treatment, according to the study. The authors said the estimated costs to Medicare are conservative and that spending on Leqembi might increase more than anticipated depending on demand and other factors. The researchers who conducted the JAMA study included physicians and public health and policy experts. They are affiliated with the Univ

[ad_1] The Alzheimer's drug Leqembi is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai | via Reuters Medicare has agreed to pay for the Alzheimer's treatment Leqembi , a major turning point for patients who are diagnosed with the early stages of the disease. Leqembi is the only drug on the market right now that has demonstrated the ability to slow the progression of early stages of Alzheimer's disease in a clinical trial. The monoclonal antibody, administered twice monthly through intravenous means, slowed cognitive decline by 27% over 18 months in the trial. Leqembi is made by Japanese drugmaker Eisai and its partner Biogen , which is based in Cambridge, Massachusetts. Medicare's decision to cover Leqembi, which came moments after the Food and Drug Administration fully approved the drug Thursday, promises to make the treatment more accessible to patients. Medicare coverage is crucial for most patients to have any hope of being

[ad_1] Jay Reinstein, who suffers from Alzheimer's, receives an injection so he can have a PET scan at MedStar Georgetown University Hospital in Washington, DC on June 20, 2023. Michael Robinson Chávez | The Washington Post | Getty Images 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.  Medicare on Thursday announced it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, broadening access for those who can't afford the d

[ad_1] The Food and Drug Administration on Thursday fully approved the Alzheimer's treatment Leqembi, a pivotal decision that will expand access to the expensive drug for older Americans. Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply. Leqembi is the first Alzheimer's antibody treatment to receive full FDA approval. It is also the first such drug that to receive broad coverage through Medicare. Leqembi is not a cure. The treatment slowed cognitive decline from early Alzheimer's disease by 27% over 18 months during Eisai's clinical trial. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer's disease. Medicare coverage is a crucial step to help older Americans with early Alzheimer's disease pay for the treatment. With a median income