The FDA has approved monthly maintenance dosing for

FDA已批准每月一次的维持剂量

Leqembi

勒克姆比

(lecanemab), a treatment for early

（lecanemab），一种用于早期治疗的药物

Alzheimer’s disease

阿尔茨海默病

.

。

The decision follows a

该决定是在

supplemental application

补充申请

from

从

Eisai

卫材

, which is codeveloping Leqembi with

，正在与之共同开发Leqembi的是

Biogen

百健公司

, based on the modeling of data from the

，基于对来自 数据的建模

Phase II Study 201 (NCT01767311)

二期研究 201 (NCT01767311)

and the

和

Phase III Clarity AD study (NCT03887455)

III 期 Clarity AD 研究 (NCT03887455)

, and their long-term extension studies, showing that once-monthly dosing can help sustain the therapy’s beneficial effects.

，及其长期扩展研究显示，每月一次的给药方案可以帮助维持该疗法的有益效果。

“The approval of once every four-week maintenance dosing of Leqembi is an important step forward in improving the care and quality of life for people living with early Alzheimer’s disease, as well as their caregivers,” George Vradenburg, chair and co-founder of

“Leqembi每四周一次的维持剂量的批准，是改善早期阿尔茨海默病患者及其护理人员的生活质量和护理水平的重要一步。”乔治·弗拉登堡，

UsAgainstAlzheimer’s

我们对抗阿尔茨海默病

, said an

，一位

organization press release

组织新闻稿

. “We are hopeful that this milestone will drive further innovation and increase access to treatments that ease the burden on both patients and their caregivers facing this devastating disease.”

“我们希望这一里程碑将推动进一步的创新，并增加获得治疗的机会，从而减轻患者及其护理人员面对这种毁灭性疾病时的负担。”

Alzheimer’s is characterized by the accumulation of toxic clumps of the protein amyloid-beta in the brain, which are thought to contribute to neurodegeneration and

阿尔茨海默病的特征是大脑中积累了一种叫做β-淀粉样蛋白的有毒团块，这些团块被认为会导致神经退行性病变和

disease symptoms

疾病症状

.

。

Given as intravenous (into-the-vein) injections, Leqembi is an antibody designed to bind and neutralize amyloid-beta protofibrils, the most neurotoxic form of the protein, which is expected to slow disease progression.

通过静脉注射给药的Leqembi是一种抗体，旨在结合并中和最具神经毒性的β-淀粉样蛋白原纤维，从而有望减缓疾病进展。

Condition:

条件：

Alzheimers

阿尔茨海默病

Type:

类型：

drug

药物