林业发展局审查了新的阿尔茨海默氏病药物LEQEMBI,该药物可通过自动注射器提供家庭治疗。
FDA reviews new Alzheimer's drug LEQEMBI, which could offer home-based treatment via autoinjector.
林业发展局已经接受了LEQEMBI的生物学许可证申请,LEQEMBI是早期阿尔茨海默氏病的一种药物,用于亚皮维护剂量。
The FDA has accepted the Biologics License Application for LEQEMBI, a drug for early Alzheimer's disease, for subcutaneous maintenance dosing.
如果得到批准,LEQEMBI将成为经林业发展局批准的唯一治疗阿尔茨海默氏病的药物,可以在家中使用自动注射器进行自我管理,有可能简化治疗,并减少住院治疗的需要。
If approved, LEQEMBI will be the only FDA-approved treatment for Alzheimer's that can be self-administered at home using an autoinjector, potentially simplifying treatment and reducing the need for hospital visits.
该药物旨在清除大脑中的氨基甲状腺素斑块,如果得到批准,可被有轻度认知障碍或早期痴呆症的患者使用。
The drug aims to clear amyloid plaques in the brain and, if approved, could be used by patients with mild cognitive impairment or early-stage dementia.
预计FDA的决定将于2025年8月31日之前作出.
The FDA's decision is expected by August 31, 2025.