FDA批准Leqembi皮下注射制剂，为阿尔茨海默病联合疗法铺平道路-动脉网

FDA Approval of Leqembi Subcutaneous Formulation Charts Path to Combination Therapies for Alzheimer's Disease

CISION 等信源发布 2025-08-30 08:01

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Subcutaneous delivery increases accessibility and introduces potential for at-home

皮下注射增加了可及性，并引入了家庭使用的潜力

administration, following model of diabetes and

管理，遵循糖尿病模型和

GLP-1

drugs

药物

NEW YORK

纽约

，

Aug. 29, 2025

2025年8月29日

/PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced its

/PRNewswire/ -- 美国食品和药物管理局 (FDA) 今天宣布了其

approval of a subcutaneous formulation of Leqembi

Leqembi的皮下注射制剂的批准

(lecanemab), branded as Leqembi Iqlik, for weekly maintenance dosing following the 18-month IV initiation phase. This is a major advancement that opens the door for faster and simpler drug delivery and paves the way for combination therapies – the same strategy that revolutionized cancer care.

（lecanemab），品牌名为Leqembi Iqlik，用于在18个月的静脉注射启动阶段之后进行每周一次的维持剂量。这一重大进展为更快、更简便的药物递送打开了大门，并为联合疗法铺平了道路——这一策略曾彻底改变了癌症治疗。

'This shift to subcutaneous maintenance dosing is a crucial step toward making Leqembi more accessible for patients, similar to how diabetes and

“这种向皮下维持剂量的转变是使Leqembi对患者更加可及的关键一步，类似于糖尿病和

GLP-1

medications are delivered, and represents the first step towards the day when patients can bypass infusions altogether,' said Dr.

药物被递送，这代表了患者完全绕过输液的第一步，”博士说。

Howard Fillit

霍华德·菲利特

, Co-Founder and Chief Science Officer at the ADDF. 'This milestone lessens the burden on patients and caregivers by reducing the logistical challenges of receiving Alzheimer's treatment, while also bringing us closer to the day when patients can more easily receive a combination of drugs, potentially administered from home.'.

，ADDF联合创始人兼首席科学官。“这一里程碑通过减少接受阿尔茨海默病治疗的后勤挑战，减轻了患者和护理人员的负担，同时也让我们离患者能够更轻松地获得药物组合的日子更近了一步，这些药物组合甚至可以在家中进行管理。”

Subcutaneous delivery means the drug can be injected just under the skin using an autoinjector once a week – taking only about 15 seconds – rather than requiring hour-long intravenous infusions in hospitals or infusion sites. While this administration method is currently only approved for maintenance dosing, Eisai and Biogen plan to file another application next week for subcutaneous dosing without the need for an IV initiation phase.

皮下注射意味着只需使用自动注射器每周一次将药物注射到皮肤下——整个过程仅需约15秒——而无需在医院或输液点进行长达一小时的静脉输液。尽管这种给药方式目前仅被批准用于维持剂量，卫材和渤健计划下周提交另一份申请，以实现无需静脉注射启动阶段的皮下给药。

As more Alzheimer's treatments progress through development and gain approval, subcutaneous formulations will likely become increasingly common..

随着越来越多的阿尔茨海默病治疗方法在研发中取得进展并获得批准，皮下注射制剂可能会变得越来越普遍。

Beyond convenience, this delivery innovation removes a critical barrier to combination therapies. With a more practical and scalable approach to drug administration, physicians will be better positioned to incorporate additional therapies that target the full spectrum of aging biology. This is especially timely as more than 70% of the .

除了便利性之外，这种递送创新消除了联合治疗的一个关键障碍。通过一种更实用、更可扩展的给药方法，医生将能够更好地结合针对衰老生物学全谱的额外疗法。这一点尤为及时，因为超过70%的。

current Alzheimer's drug pipeline

当前的阿尔茨海默病药物研发管线

focuses on non-amyloid pathways.

专注于非淀粉样蛋白途径。

'We've long known that Alzheimer's is not a one-target disease, and the future lies in precision combination therapies tailored to each patient based on their individual biomarker profiles,' Dr. Fillit said. 'Subcutaneous delivery is more than an upgrade – it's a gateway to the next generation of Alzheimer's care, accelerating our ability to bring effective, multi-modal treatment regimens to the millions of patients who need them.'.

“我们早就知道阿尔茨海默病不是一种单一靶点的疾病，未来在于根据每个患者的个体生物标志物特征量身定制的精准联合疗法，”菲尔利特博士说。“皮下注射不仅仅是一个升级——它是通往下一代阿尔茨海默病护理的门户，加速了我们为数百万需要的患者提供有效、多模式治疗方案的能力。”

About The Alzheimer's Drug Discovery Foundation (ADDF)

关于阿尔茨海默病药物发现基金会 (ADDF)

Founded in 1998 by Leonard A. and

由伦纳德·A.于1998年创立

Ronald S. Lauder

罗纳德·S·劳德

, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the development of drugs to prevent, treat, and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry.

，阿尔茨海默病药物发现基金会致力于加速开发预防、治疗和治愈阿尔茨海默病的药物。ADDF是唯一一家专注于为阿尔茨海默病药物开发提供资金的公共慈善机构，采用风险慈善模式支持学术界和生物技术行业的研究。

The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid.

ADDF的领导和贡献在推动首个阿尔茨海默病PET扫描（Amyvid）方面发挥了关键作用。

) and blood test (PrecivityAD

）和血液测试（PrecivityAD

) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than

）推向市场，同时也为当前强大且多样化的药物研发管线提供动力。通过其捐赠者的慷慨解囊，ADDF已颁发了超过

$370 million

3.7亿美元

to fund 765 Alzheimer's drug development, biomarker, and prevention programs in 21 countries. To learn more, please visit:

为21个国家的765个阿尔茨海默病药物开发、生物标志物和预防项目提供资金。欲了解更多信息，请访问：

http://www.alzdiscovery.org/