INDIANAPOLIS, Oct. 23, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for donanemab, an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in eligible adults in Great Britain.

印第安纳波利斯，2024年10月23日/PRNewswire/--礼来公司（纽约证券交易所：LLY）今天宣布，药品和保健产品监管局（MHRA）已批准多纳单抗的上市许可，多纳单抗是一种每四周静脉输注一次的注射剂，用于治疗英国符合条件的成年人因阿尔茨海默氏病引起的轻度认知障碍和轻度痴呆。

Eligible patients are limited to apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, which is a requirement for the class of currently approved amyloid-targeting therapies in Great Britain. Donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.

符合条件的患者仅限于载脂蛋白Eε4（ApoEε4）杂合子或非携带者，这是英国目前批准的淀粉样蛋白靶向治疗类别的要求。Donanemab是唯一一种针对淀粉样斑块的治疗方法，有证据支持在去除淀粉样斑块时停止治疗。

Great Britain is the third major market to approve donanemab, marketed as Kisunla..

英国是第三个批准donanemab的主要市场，市场名称为Kisulla。。

'People around the world want and deserve access to treatment options for this disease. This approval in Great Britain is another significant step to ensure patients with Alzheimer's disease can receive treatment with this new class of amyloid targeting therapies, which could give them more time in the early symptomatic stage of the disease to do what matters most to them,' said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company.

“世界各地的人们都希望并理应获得这种疾病的治疗选择。礼来国际（EliLilly and Company）执行副总裁兼总裁伊利亚·尤法（IlyaYuffa）说，英国的这一批准是确保阿尔茨海默氏病患者可以接受这种新型淀粉样蛋白靶向疗法治疗的又一重要步骤，这可以让他们在疾病的早期症状阶段有更多的时间做对他们最重要的事情。

'Donanemab demonstrated meaningful results for people with early symptomatic Alzheimer's disease by significantly slowing cognitive and functional decline in our TRAILBLAZER-ALZ 2 study.' .

“在我们的TRAILBLAZER-ALZ 2研究中，Donanemab通过显着减缓认知和功能下降，为早期症状性阿尔茨海默氏病患者证明了有意义的结果。”。

Currently, there are 982,000 people estimated to be living with dementia in the United Kingdom (UK)1, with 50-75% of cases attributable to Alzheimer's disease.2 It is the leading cause of death3 in the UK and an economic cost to society. The total cost of dementia on patients, families and the public sector is estimated to be £42 billion in 2024.

目前，英国（UK）估计有982000人患有痴呆症1，其中50-75%的病例可归因于阿尔茨海默病。2它是英国死亡的主要原因3，也是社会的经济成本。2024年，痴呆症对患者、家庭和公共部门的总成本估计为420亿英镑。

Unpaid care is the largest component, with costs per person increasing threefold from mild to severe dementia.4.

无偿护理是最大的组成部分，从轻度到重度痴呆症，人均费用增加了三倍。

Amyloid is a protein produced naturally in the body that can clump together to create amyloid plaques. The excessive buildup of amyloid plaques in the brain may lead to memory and thinking issues associated with Alzheimer's disease.  Donanemab can help the body remove the excessive buildup of amyloid plaques and slow the cognitive and functional decline that may diminish people's ability to remember information, make meals, manage finances, and maintain independence.  .

淀粉样蛋白是一种在体内自然产生的蛋白质，可以聚集在一起形成淀粉样斑块。大脑中淀粉样斑块的过度累积可能导致与阿尔茨海默病相关的记忆和思维问题。多纳单抗可以帮助身体消除淀粉样斑块的过度堆积，减缓认知和功能衰退，这可能会削弱人们记忆信息、做饭、管理财务和保持独立的能力。。

'I believe we can improve the standard of care for people living with Alzheimer's disease. Despite years of medical research, until recently, there has been little progress in treatment options for this disease. The authorisation of donanemab for eligible adults is welcome news. Great Britain now needs to rapidly increase National Health Service (NHS) capacity and expertise in diagnostics and treatment facilities to enhance the management of Alzheimer's disease for the benefit of people today and tomorrow,' said Professor Cath Mummery, Consultant Neurologist at University College London Hospitals NHS Foundation Trust and Chair of the NIHR Dementia Translational Research Collaboration..

“我相信我们可以提高阿尔茨海默病患者的护理水平。尽管进行了多年的医学研究，但直到最近，这种疾病的治疗选择几乎没有进展。donanemab对符合条件的成年人的授权是一个受欢迎的消息。伦敦大学学院医院NHS基金会信托基金会顾问神经科医生兼NIHR痴呆症转化研究合作主席凯斯·穆默里教授说，英国现在需要迅速提高国家卫生服务（NHS）在诊断和治疗设施方面的能力和专业知识，以加强对阿尔茨海默氏病的管理，造福于今天和明天的人们。。

About Donanemab Donanemab is an amyloid-targeting treatment for people with mild cognitive impairment and mild dementia due to Alzheimer's disease in adult patients who are apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. Donanemab can cause serious side effects, including amyloid-related imaging abnormalities (ARIA), and infusion-related reactions. Donanemab is a fixed dose prescription medicine administered intravenously every four weeks. .

关于Donanemab Donanemab是一种针对载脂蛋白Eε4（ApoEε4）杂合子或非携带者的成年患者的轻度认知障碍和轻度痴呆患者的淀粉样蛋白靶向治疗。多纳单抗可引起严重的副作用，包括淀粉样蛋白相关的成像异常（ARIA）和输注相关反应。多纳单抗是一种固定剂量的处方药，每四周静脉注射一次。。

About TRAILBLAZER-ALZ 2 Study and the TRAILBLAZER-ALZ programTRAILBLAZER-ALZ 2 (NCT04437511) is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology.

关于TRAILBLAZER-ALZ 2研究和TRAILBLAZER-ALZ程序TRAILBLAZER ALZ 2（NCT04437511）是一项3期双盲安慰剂对照研究，用于评估多纳单抗在早期症状性阿尔茨海默病（轻度认知障碍或阿尔茨海默病引起的轻度痴呆）参与者中的安全性和有效性，并存在确诊的阿尔茨海默病神经病理学。

The trial enrolled 1,736 participants, across 8 countries, selected based on cognitive assessments in conjunction with evidence of Alzheimer's disease pathology. The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA)..

该试验招募了来自8个国家的1736名参与者，这些参与者是根据认知评估和阿尔茨海默病病理学证据选择的。第三阶段TRAILBLAZER-ALZ 2研究结果发表在《美国医学会杂志》（JAMA）上。。

Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, which is focused on reducing risk of progression to symptomatic Alzheimer's disease in participants with preclinical AD; TRAILBLAZER-ALZ 5, a registration trial for early symptomatic AD currently enrolling in China and Korea; and TRAILBLAZER-ALZ 6, which is focused on expanding our understanding of ARIA through novel MRI sequences, blood-based biomarkers, and different dosing regimens of donanemab..

礼来继续在多项临床试验中研究多纳单抗，包括TRAILBLAZER-ALZ 3，该试验旨在降低临床前AD患者进展为症状性阿尔茨海默病的风险；TRAILBLAZER-ALZ 5是一项针对早期症状性AD的注册试验，目前正在中国和韩国注册；和TRAILBLAZER-ALZ 6，它专注于通过新的MRI序列，基于血液的生物标志物和多纳单抗的不同给药方案来扩展我们对ARIA的理解。。

About Lilly  Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases.

关于礼来 礼来是一家将科学转化为治疗的医药公司，旨在让世界各地的人们生活得更好。近150年来，我们一直在开创改变生活的发现，今天，我们的药物帮助了全球数以千万计的人。利用生物技术、化学和遗传医学的力量，我们的科学家正在迫切推进新发现，以解决世界上一些最重大的健康挑战：重新定义糖尿病护理；治疗肥胖并减少其最具破坏性的长期影响；推进与阿尔茨海默病的斗争；为一些最致命的免疫系统疾病提供解决方案；并将最难治疗的癌症转化为可控制的疾病。

With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn.

在迈向更健康世界的每一步中，我们都有一个动机：让数百万人的生活变得更好。这包括提供反映我们世界多样性的创新临床试验，并努力确保我们的药物可获得且负担得起。要了解更多信息，请访问Lilly.com和Lilly.com/news，或在Facebook、Instagram和LinkedIn上关注我们。