Patients on Alzheimer's drug Leqembi see benefits over three years, Eisai study says

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The newly FDA approved Alzheimer's treatment Leqembi is prepared at Abington Neurological Associates in Abington, PA., on Tuesday, November 7, 2023. The breakthrough Alzheimer's drug Leqembi slowed disease progression in patients over three years, demonstrating the need for them to stay on the treatment long term, according to new data released Tuesday by Japanese drugmaker Eisai. The study results on Leqembi, which Eisai shares with Biogen , also found that a patient's Alzheimer's disease worsens after they stop treatment. Rates of adverse side effects associated with Leqembi, including brain bleeding and swelling, dropped after six months of treatment, Dr. Lynn Kramer, Eisai's chief clinical officer of deep human biology learning, told CNBC. That decline is critical: Those side effects in the brain have raised concerns among some doctors and are the main reason a European drug regulator recommended against approving Leqembi last week. The study is the longest available efficacy and safety data to date on Leqembi, which has had a bumpy rollout in the U.S. since winning regulatory approval last summer due to bottlenecks related to diagnostic test requirements and regular brain scans, among other issues. Eisai released 24-month data on Leqembi in November. Eisai presented the findings on Tuesday at the Alzheimer's Association International Conference in Philadelphia, the world's largest meeting for dementia research. The results are a first glimpse at what Alzheimer's patients' future could look like on therapies such as Leqembi, which is currently taken twice a month through an infusion. The drug is a monoclonal antibody that targets toxic plaques in the brain called amyloid, a hallmark of Alzheimer's, to slow the progression of the disease during its early stages. Leqembi also works by clearing protofibrils, the building blocks of amyloid plaque. The data demonstrates the importance of early and sustained treatment for people living with the notoriously hard-to-treat brain disorder — even after a drug clears a patient's amyloid plaque. "Continuing treatment is important if you would like to maintain cognition and functionality longer," Kramer said. While Leqembi is not a cure, "if you start early enough, it can give you years of benefit," he said. Kramer added that Eisai believes patients can eventually switch to a maintenance dose of Leqembi after roughly 18 to 24 months of treatment, which could be a less frequent or more convenient way to take the drug over a long period. Eisai and Biogen are seeking regulatory approval for a once-monthly infusion of Leqembi, with a decision expected in January. The drugmakers also aim to bring to the market an injectable form of Leqembi that patients can take at home once a week. "Those two things will change the paradigm, make it easier for the patient, make it easier for the whole medical system," Kramer said in an interview. Nearly 7 million Americans have the condition, the fifth-leading cause of death for adults over 65, according to the Alzheimer's Association. By 2050, the number of Alzheimer's patients is projected to rise to almost 13 million in the U.S.