澳大利亚治疗用品管理局决定不注册lecanemab-动脉网

Therapeutic Goods Administration decides not to register lecanemab in Australia

CISION 等信源发布 2025-03-03 16:21

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可切换为仅中文

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

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STOCKHOLM, Sweden

瑞典，斯德哥尔摩

，

March 3, 2025

2025年3月3日

/PRNewswire/ --

BioArctic AB's (publ)

BioArctic AB（公众公司）

(NASDAQ:

（纳斯达克：

BIOA

生物应用

B) (

STOCKHOLM

斯德哥尔摩

: BIOA B)

：BIOA B）

partner Eisai announced today that the Therapeutic Goods Administration (TGA) of

合作伙伴卫材今天宣布，治疗用品管理局 (TGA)

Australia

澳大利亚

has declined the approval of lecanemab (generic name) as a treatment for early Alzheimer's disease (AD) (mild cognitive impairment due to AD and mild AD dementia). Eisai remains committed to ensuring eligible Australians with early Alzheimer's disease can access lecanemab and is exploring options to achieve this, including potentially seeking review by the Administrative Review Tribunal..

已拒绝批准lecanemab（通用名）作为治疗早期阿尔茨海默病（AD）（由AD引起的轻度认知障碍和轻度AD痴呆）的药物。卫材仍然致力于确保符合条件的澳大利亚早期阿尔茨海默病患者能够获得lecanemab，并正在探索实现这一目标的选项，包括可能寻求行政审查法庭的复审。

在

October 2024

2024年10月

, the TGA made the decision not to register lecanemab in

，TGA决定不在以下地区注册lecanemab

Australia

澳大利亚

for the treatment of patients with early AD. In

用于治疗早期阿尔茨海默病患者。在

December 2024

2024年12月

, Eisai requested reconsideration of the decision, proposing to the TGA the same apolipoprotein E4 (ApoE4) noncarrier and heterozygote indication that was agreed by the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA). In the course of the reconsideration of the initial decision, the TGA proposed an alternative narrow therapeutic indication only for ApoE4 noncarriers as an increasing number of ApoE4 alleles is a potential risk factor for ARIA.

，卫材请求对决定进行重新考虑，并向澳大利亚治疗用品管理局（TGA）提出了与英国药品和健康产品管理局（MHRA）及欧洲药品管理局（EMA）商定的相同的非ApoE4携带者和杂合子适应症。在对初始决定的重新审议过程中，由于ApoE4等位基因数量增加是ARIA的潜在风险因素，TGA提出了仅针对非ApoE4携带者的另一种狭窄治疗适应症。

They did not agree that safety has been established for ApoE4 heterozygotes. Eisai proposed alternative indications, one of which was to maintain the ApoE4 noncarrier and heterozygote indication, but with heterozygotes treated in specialist centers and supervised by physicians with expertise in treatment of AD and monitoring for ARIA; however, the TGA rejected Eisai's proposal. .

他们并不认同ApoE4杂合子的安全性已经得到确立。卫材提出了替代适应症，其中之一是保留ApoE4非携带者和杂合子的适应症，但杂合子需在专业中心接受治疗，并由在AD治疗和ARIA监测方面具有专业知识的医生进行监督；然而，TGA拒绝了卫材的提议。

'We are very disappointed with the TGA's decision. Foremost it is sad for all patients, caregivers and healthcare professionals in

“我们对TGA的决定感到非常失望。首先，这对所有患者、护理人员和医疗专业人员来说是令人难过的。

Australia

澳大利亚

who will now have to wait longer for a treatment which can effectively change the course of this devastating disease. We know that for these patients, time is what they value the most and denying them a treatment which has been shown to delay the onset of more severe stages of the diseases is of course not what they or we had hoped for,' said .

这些患者现在将不得不等待更长时间才能接受一种可以有效改变这种毁灭性疾病进程的治疗。我们知道，对于这些患者来说，时间是他们最看重的，剥夺他们一种已被证明可以延缓疾病更严重阶段发作的治疗，当然不是他们或我们所希望的。

Gunilla Osswald

吉尼拉·奥斯瓦尔德

, CEO at BioArctic.

，BioArctic首席执行官。

在

Australia

澳大利亚

, the number of people living with dementia was estimated to be approximately 411,000 in 2023, and is reported to increase to approximately 849,000 by 2058.

，据估计，2023年约有411,000人患有痴呆症，到2058年预计将增加到约849,000人。

[1]

AD is considered the most common cause of dementia, typically accounting for 60-70% of cases.

AD 被认为是痴呆症最常见的原因，通常占病例的 60-70%。

[2]

AD progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with AD and their care partners. There is a significant unmet need for new treatment options that slow down the progression of AD from its early stage and reduce the overall burden on people affected by AD and society..

阿尔茨海默病（AD）按阶段进展，严重程度随时间增加，疾病的每个阶段都给患者及其护理伙伴带来不同的挑战。目前迫切需要新的治疗方案来减缓阿尔茨海默病从早期开始的进展，并减轻患者和社会所承受的总体负担。

Aβ which is involved in the onset of AD, gradually aggregates in the brain 15 to 20 years before symptoms appear, eventually forming insoluble plaques, a pathological feature of AD. AD is a progressive, relentless disease caused by a continuous underlying neurotoxic process that begins before and continues after plaque removal..

β淀粉样蛋白（Aβ）与AD发病相关，在症状出现前的15至20年里逐渐在大脑中聚集，最终形成不溶性斑块，这是AD的病理特征。AD是一种进行性的、无情的疾病，由一种持续的潜在神经毒性过程引起，该过程在斑块清除之前开始并在此之后继续。

[3]

，

[4]

，

[5]

Lecanemab works to fight AD in two ways: continuously clearing protofibrils, the most toxic Aβ species, and rapidly clearing plaque. This mechanism has been shown to reduce the rate of disease progression and to slow cognitive and functional decline.

Lecanemab通过两种方式对抗AD：持续清除原纤维，这是最具毒性的Aβ种类，以及快速清除斑块。该机制已被证明可以降低疾病进展的速度，并减缓认知和功能的衰退。

Lecanemab has so far been approved in 11 markets including the U.S.,

lecanemab目前已在美国等11个市场获得批准，

Japan

日本

，

China

中国

and the

和

United Kingdom

英国

. Regulatory filings for the treatment have been made in the EU and 17 other countries and regions In the EU, in

该治疗方案已在欧盟和其他17个国家及地区提交了监管文件，在欧盟境内，

February 2025

2025年2月

, the Committee for Medicinal Products for Human Use reaffirmed its positive opinion for lecanemab in early AD, adopted in

人用医药产品委员会重申了其对早期阿尔茨海默病（AD）的lecanemab的积极意见，该意见是在

November 2024

2024年11月

, and the European Commission is proceeding with the decision-making process for lecanemab's marketing authorization.

，欧洲委员会正在推进lecanemab的上市许可决策过程。

Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor

Leqembi 是 BioArctic 与卫材长期合作的成果，该抗体最初由 BioArctic 基于教授的工作开发。

Lars Lannfelt

拉尔斯·兰菲尔特

and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Lecanemab for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and currently, the two companies are preparing for a joint commercialization in the region. .

他在阿尔茨海默病领域发现了北极突变。卫材负责Lecanemab在阿尔茨海默病方面的临床开发、上市申请及商业化。BioArctic拥有与卫材共同在北欧地区将Leqembi商业化的权利，目前两家公司正在为在该地区的联合商业化做准备。

The information was released for public disclosure, through the agency of the contact person below, on

该信息通过以下联络人发布，供公众披露，

March 3, 2025

2025年3月3日

, at

，在

09:00 CET

09:00 中欧时间

。

For further information, please contact:

如需更多信息，请联系：

Oskar Bosson

奥斯卡·博森

, VP Communications and IR

，副总裁，传播与投资者关系

E-mail:

电子邮件：

oskar.bosson@bioarctic.com

Phone: +46 70 410 71 80

电话：+46 70 410 71 80

Charlotte af Klercker, Director Communications and Sustainability

夏洛特·阿夫·克勒克，传播与可持续发展总监

E-mail:

电子邮件：

charlotte.afklercker@bioarctic.com

夏洛特·阿夫克勒克@bioarctic.com

Phone: +46 73 515 09 70

电话：+46 73 515 09 70

About lecanemab (Leqembi

关于lecanemab（Leqembi）

)

Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Lecanemab 是 BioArctic 与卫材战略研究联盟的成果。它是一种人源化的免疫球蛋白伽马 1（IgG1）单克隆抗体，针对淀粉样蛋白-beta（Aβ）的聚集可溶性（原纤维）和不溶性形式。

Lecanemab is approved in the U.S.,

Lecanemab 已在美国获批，

Japan

日本

，

China

中国

，

United Kingdom

英国

, and several other markets for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's positive opinion in

，以及包括阿尔茨海默病（AD）引起的轻度认知障碍（MCI）和轻度AD痴呆在内的多个其他市场。Lecanemab在这些国家的批准，以及CHMP的积极意见

November 2024

2024年11月

, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai has also submitted applications for regulatory approval of lecanemab in several other countries and regions..

，主要基于卫材在全球Clarity AD临床试验中的第三阶段数据，该试验达到了其主要终点和所有关键次要终点，并取得了具有统计学意义的结果。卫材还向其他几个国家和地区提交了lecanemab的监管审批申请。

A supplemental Biologics License Application (sBLA) for less frequent intravenous maintenance dosing was approved by the U.S. Food and Drug Administration (FDA) in

美国食品药品监督管理局（FDA）批准了减少静脉注射维持剂量的补充生物制品许可申请（sBLA）。

January 2025

2025年1月

. In

。在

January 2025

2025年1月

, the rolling submission of a Biologics License Application (BLA) for maintenance dosing of a subcutaneous auto injection formulation, which is being developed to enhance convenience for patients, was accepted in the U.S., with PDUFA date

，美国已接受为维持剂量的皮下自动注射制剂（正在开发以提高患者便利性）所提交的生物制品许可申请（BLA）的滚动审评，PDUFA日期为

August 31

8月31日

, 2025.

，2025年。

Since

自从

July 2020

2020年7月

, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in

，卫材针对临床前阿尔茨海默病（AD）患者使用Lecanemab的III期临床研究（AHEAD 3-45）正在进行中。这些患者临床表现正常，但大脑中具有中等或较高水平的淀粉样蛋白。该研究已完成全部招募。

October 2024

2024年10月

. AHEAD 3-45 is a four-year study conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai.

AHEAD 3-45 是一项为期四年的研究，由阿尔茨海默病临床试验联盟与美国国家老龄化研究所（隶属于美国国立卫生研究院）和卫材公司合作开展的公私合作伙伴关系进行，该联盟为美国境内阿尔茨海默病及相关痴呆症的学术临床试验提供基础设施，并由国家老龄化研究所资助。

Since .

自以来。

January 2022

2022年1月

, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by

，由显性遗传阿尔茨海默病网络试验组（DIAN-TU）主导的显性遗传阿尔茨海默病（DIAD）的Tau NexGen临床研究，

Washington University

华盛顿大学

School of Medicine in

医学院在

St. Louis

圣路易斯

, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

，正在进行中，并包括lecanemab作为基础抗淀粉样蛋白疗法。

About the collaboration between BioArctic and Eisai

关于BioArctic与Eisai的合作

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015.

自2005年以来，BioArctic与卫材在开发和商业化用于治疗阿尔茨海默病的药物方面有着长期的合作关系。最重要的协议包括2007年签署的lecanemab抗体的开发和商业化协议，以及2015年签署的用于阿尔茨海默病的Leqembi备用抗体的开发和商业化协议。

In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.

2014年，卫材和渤健就lecanemab签订了共同开发和商业化协议。卫材负责阿尔茨海默病产品的临床开发、上市申请和商业化。BioArctic在某些条件下有权在北欧地区将lecanemab商业化，目前正与卫材一起准备在北欧地区的商业化。

BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales. .

BioArctic无需承担lecanemab在阿尔茨海默病中的开发成本，并有权获得与监管批准、销售里程碑相关的付款，以及全球销售额的特许权使用费。

About BioArctic AB

关于BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company is the originator of Leqembi

BioArctic AB（publ）是一家瑞典研究型生物制药公司，专注于开发能够延缓或阻止神经退行性疾病进展的创新疗法。该公司是Leqembi的原研者。

(lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with Eisai. BioArctic has a broad research portfolio within Alzheimer's disease, Parkinson's disease, ALS and enzyme deficiency diseases.

（lecanemab）——全球首款被证实可以减缓疾病进展并减轻早期阿尔茨海默病认知障碍的药物。Leqembi由卫材共同开发。BioArctic在阿尔茨海默病、帕金森病、肌萎缩侧索硬化症和酶缺乏疾病方面拥有广泛的研究组合。

Several of the projects utilize the company's proprietary BrainTransporter™ technology, which improves the transport of drugs into the brain. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap..

几个项目利用了该公司的专有技术BrainTransporter™，这项技术可以改善药物向大脑的传输。BioArctic的B股（BIOA B）在纳斯达克斯德哥尔摩大型股上市。

For more information, please visit

更多信息，请访问

www.bioarctic.com

。

[1]

Dementia in

痴呆症

Australia

澳大利亚

https://www.aihw.gov.au/reports/dementia/dementia-in-aus/contents/population-health-impacts-of-dementia/prevalence-of-dementia

[2]

World Health Organization. Dementia Fact Sheet.

世界卫生组织。痴呆症事实表。

March 2023

2023年3月

. Available at:

。可于以下地址获取：

https://www.who.int/news-room/fact-sheets/detail/dementia

[3]

Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer's disease at Clinical Trials on Alzheimer's Disease (CTAD) conference. Available at:

卫材在阿尔茨海默病临床试验（CTAD）会议上展示了lecanemab针对早期阿尔茨海默病的3期验证性Clarity AD研究的完整结果。可用链接：

https://www.eisai.co.jp/news/2022/news202285.html

[4]

van Dyck, H., et al. Lecanemab in Early Alzheimer's Disease. New England Journal of Medicine. 2023;388:9-21.

范戴克，H.，等。Lecanemab在早期阿尔茨海默病中的应用。《新英格兰医学杂志》。2023年；388:9-21。

https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

[5]

Hampel H, Hardy J, Blennow K, et al. The amyloid-β pathway in Alzheimer's disease. Mol Psychiatry. 2021;26(10):5481-5503

汉佩尔 H，哈迪 J，布伦诺 K，等。阿尔茨海默病中的淀粉样β途径。《分子精神病学》。2021；26（10）：5481-5503。

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