第1882期:US Approves Drug to Slow Early Effects of Alzheimer’s Disease

U.S. officials gave full approval last week to Leqembi, a drug that moderately slows Alzheimer’s disease. The disease affects the brain causing memory loss and dementia. The Food and Drug Administration (FDA) approval means the government’s health coverage, Medicare, and other health insurance plans will help pay for the drug’s cost. The FDA approved Leqembi for patients with mild dementia and other effects caused during the early stages of Alzheimer’s. Leqembi is the first medicine shown to moderately slow the mental loss caused by Alzheimer’s disease. The drug helps remove proteins that stick together and damage the brain.

美国官员上周完全批准了 Leqembi，这是一种可适度减缓阿尔茨海默病的药物。 这种疾病影响大脑，导致记忆丧失和痴呆。美国食品和药物管理局 (FDA) 的批准意味着政府的健康保险、医疗保险和其他健康保险计划将有助于支付该药物的费用。FDA 批准 Leqembi 用于治疗患有轻度痴呆症和阿尔茨海默病早期阶段引起的其他影响的患者。Leqembi 是第一种被证明可以适度减缓阿尔茨海默病引起的精神损失的药物。 该药物有助于去除粘在一起并损害大脑的蛋白质。

Final approval came after the FDA considered a study of 1,800 patients. The study showed the drug slowed losses in memory and decreases in thinking by about five months in those who received the medicine compared to those who received an ineffective substance. The drug carries a warning for serious side effects, such as possible bleeding in the brain. The warning notes that these side effects are found in other drugs that target harmful brain proteins. Last year, Medicare announced it would not pay for the drug unless the FDA gave it full approval. As a result, Alzheimer’s patients and people supporting them pushed for final approval. A year’s supply of Leqembi costs about $26,500. It is injected every two weeks. Some experts worry the drug’s cost is too high. Medicare pays health care costs for about 60 million Americans aged 65 or older.

FDA 在考虑了一项针对 1,800 名患者的研究后最终获得批准。 研究表明，与服用无效药物的人相比，服用该药物的人的记忆力丧失和思维能力下降速度减缓了约五个月。该药物带有严重副作用的警告，例如可能导致脑出血。 警告指出，这些副作用也存在于其他针对有害脑蛋白的药物中。去年，医疗保险宣布，除非 FDA 完全批准，否则不会支付该药物的费用。 因此，阿尔茨海默氏症患者和支持他们的人们极力争取最终批准。一年的 Leqembi 供应成本约为 26,500 美元。 每两周注射一次。 一些专家担心这种药物的成本太高。 医疗保险为大约 6000 万 65 岁或以上的美国人支付医疗费用。

Medicare administrator Chiquita Brooks-LaSure confirmed last week that the program will begin paying for the drug now that it has full FDA approval. But the government is also requiring patients who receive the drug to enter a program that will collect information about the drug’s safety and effectiveness. Medicare “will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” Brooks-LaSure said. Some Medicare patients may have to pay for 20 percent of the cost of Leqembi. However, the amount will depend on the details of their insurance coverage plan.

医疗保险管理者 Chiquita Brooks-LaSure 上周证实，该计划将开始支付该药物的费用，因为该药物已获得 FDA 的全面批准。但政府还要求接受该药物的患者参加一项计划，该计划将收集有关该药物的安全性和有效性的信息。布鲁克斯-拉苏尔说，医疗保险“将广泛覆盖这种药物，同时继续收集数据，帮助我们了解这种药物的作用原理”。一些 Medicare 患者可能需要支付 Leqembi 费用的 20%。 但是，金额将取决于其保险计划的详细信息。

Hospitals and medical clinics have said it might take time to get people started on the drug. Doctors will need to test patients for the sticky brain proteins targeted by Leqembi. Nurses need to learn how to give the drug, which needs to be administered by intravenous injection.Patients also must undergo regular brain scans to look for bleeding or swelling. These brain images carry extra costs for hospitals. Japanese drug-maker Eisai developed Leqembi. The drug is co-marketed with Biogen, a company based in the eastern U.S. state of Massachusetts. Some Alzheimer’s experts say patients, or their families might not notice the moderate difference the drug makes. But federal health advisors said the difference was important enough for them to suggest in June that the FDA approve the drug.

医院和医疗诊所表示，让人们开始使用这种药物可能需要一些时间。 医生需要测试患者体内 Leqembi 靶向的粘性脑蛋白。 护士需要学习如何给药，该药物需要通过静脉注射给药。患者还必须定期接受脑部扫描以检查是否有出血或肿胀。 这些大脑图像给医院带来了额外的费用。日本制药商卫材 (Eisai) 开发了 Leqembi。 该药物与总部位于美国东部马萨诸塞州的 Biogen 公司共同销售。一些阿尔茨海默氏症专家表示，患者或其家人可能没有注意到该药物所带来的轻微差异。 但联邦健康顾问表示，这一差异非常重要，足以让他们在 6 月份建议 FDA 批准该药物。