INDIANAPOLIS, Sept. 24, 2024 /PRNewswire/ -- The Ministry of Health, Labour and Welfare Japan has approved Kisunla™ (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion), Eli Lilly and Company's (NYSE: LLY) Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology..

印第安纳波利斯，2024年9月24日/PRNewswire/--日本厚生劳动省已批准Kisunla™（donanemab azbt，每四周注射350毫克/20毫升静脉输注），礼来公司（纽约证券交易所：LLY）对患有早期症状性阿尔茨海默氏病（AD）的成年人进行阿尔茨海默氏病治疗，其中包括轻度认知障碍（MCI）患者以及轻度痴呆阶段的AD患者，确诊为淀粉样蛋白病理。。

Japan is the second major market in which Kisunla has been approved for use. In Japan, by 2030, the number of patients with dementia is estimated to be more than 5 million1, and AD is the most common cause of dementia, accounting for more than 67% of cases2. The number of AD patients is expected to increase significantly compared with other dementias.3 .

日本是Kisunla获准使用的第二大市场。在日本，到2030年，痴呆症患者人数估计超过500万1，AD是痴呆症的最常见原因，占病例的67%以上2。。

'Lilly scientists have been dedicated to research in Alzheimer's disease for more than 35 years, and this news is testament to their ingenuity, perseverance, and commitment to helping people with this disease,' said Ilya Yuffa, executive vice president and president of Lilly International, Eli Lilly and Company.

礼来国际执行副总裁兼总裁伊利亚·尤法（IlyaYuffa）说：“礼来的科学家致力于阿尔茨海默氏病的研究已有35多年的历史，这一消息证明了他们的聪明才智、毅力和对帮助阿尔茨海默氏病患者的承诺。”。

'Kisunla demonstrated very meaningful results for people with early symptomatic Alzheimer's disease by significantly slowing cognitive and functional decline in our TRAILBLAZER-ALZ 2 study, which included participants from Japan. People around the world want and deserve access to treatment options for this devastating disease.

“Kisunla在我们的TRAILBLAZER-ALZ 2研究（包括来自日本的参与者）中显着减缓了认知和功能下降，为早期症状性阿尔茨海默氏病患者证明了非常有意义的结果。世界各地的人们都希望并理应获得这种毁灭性疾病的治疗选择。

Today's news is another critical step in ensuring patients with Alzheimer's disease can receive treatment with these first class of amyloid therapies, which could give them more time to do what matters most to them.' .

今天的新闻是确保阿尔茨海默病患者能够接受这些第一类淀粉样蛋白疗法治疗的另一个关键步骤，这可以让他们有更多的时间做对他们来说最重要的事情。”。

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.4,5 Kisunla can help the body remove the excessive buildup of amyloid plaques and slow the decline that may diminish people's ability to remember new information, important dates, and appointments; plan and organize; make meals; use household appliances; manage finances; and be left alone.4-7.

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[4,5]。Kisunla可以帮助身体消除淀粉样斑块的过度累积，并减缓可能降低人们记忆新信息，重要日期和约会能力的衰退；计划和组织；做饭；使用家用电器；管理财务；。

'Alzheimer's disease is a significant healthcare burden in Japan due to the rapidly aging population. We are excited to make Kisunla available in Japan as a new treatment option for early symptomatic Alzheimer's disease,' said Yanping Wang, senior vice president of Drug Development and Medical Affairs at Eli Lilly Japan.

“由于人口迅速老龄化，阿尔茨海默病在日本是一项重大的医疗负担。礼来日本药品开发和医疗事务高级副总裁王延平（Yanping Wang）说，我们很高兴能在日本推出Kisulla，作为早期症状性阿尔茨海默病的新治疗选择。

'Patients treated with Kisunla may have the option to stop treatment once the amyloid plaques are removed, which could help reduce the infusion burden for eligible patients.'.

“一旦淀粉样斑块被清除，接受Kisunla治疗的患者可以选择停止治疗，这可能有助于减轻符合条件的患者的输液负担。”。

Results from the TRAILBLAZER-ALZ 2 Phase 3 StudyThe application to the PMDA was based on the efficacy and safety data from TRAILBLAZER-ALZ 2 Phase 3 clinical study.

TRAILBLAZER-ALZ 2期3期研究的结果PMDA的应用基于TRAILBLAZER-ALZ 2期3期临床研究的有效性和安全性数据。

In the TRAILBLAZER-ALZ 2 Phase 3 study, people who were the least advanced in the disease experienced the strongest results with Kisunla. Trial participants were analyzed over 18 months in two groupings: one group who was less advanced in their disease (those with low to medium levels of tau protein) and the overall population, which also included participants with high tau levels.8-10 Treatment with Kisunla significantly slowed clinical decline in both groups.8  Those individuals treated with Kisunla who were less advanced in their disease showed a significant slowing of decline of 35% compared with placebo on the integrated Alzheimer's Disease Rating Scale (iADRS), which measures memory, thinking, and daily functioning.

在TRAILBLAZER-ALZ 2期3期研究中，该疾病进展最慢的人在Kisunla中经历了最强的结果。试验参与者在18个月内分为两组进行分析：一组患者病情较轻（tau蛋白水平低至中等），另一组患者也包括tau蛋白水平较高的参与者。8-10使用kisulla治疗显着减缓了两组患者的临床下降[8]。在综合阿尔茨海默病评定量表（iADRS）上，接受kisulla治疗的患者与安慰剂相比，病情较轻的患者的下降速度显着减慢了35%，该量表测量了记忆，思维和日常功能。

In the overall population, the response to treatment was also statistically significant using the iADRS at 22%.8, 11 Among the two groups analyzed, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking placebo.12   .

在总体人群中，使用iADRS对治疗的反应也具有统计学意义，为22%[8,11]。在所分析的两组中，用Kisulla治疗的参与者进展到下一个临床阶段的风险降低了39%比服用安慰剂的人。

Among the overall population of participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study.8, 13 One of the treatment goals of the study was to remove amyloid plaques to minimal levels consistent with a visually negative scan using amyloid positron emission tomography (PET).

在参与者的总体人群中，与研究开始时相比，Kisunla在6个月时平均减少了61%，在12个月时平均减少了80%，在18个月时平均减少了84%[8,13]。研究的治疗目标之一是使用淀粉样正电子发射断层扫描（PET）将淀粉样斑块去除到与视觉阴性扫描一致的最低水平。

If participants were confirmed to have reached these levels, they were able to complete treatment with Kisunla and switch to placebo for the remainder of the study. In the TRAILBLAZER-ALZ 2 study, 66% of patients achieved plaque clearance (based on above criteria) at one year.14.

如果参与者被证实达到了这些水平，他们就能够完成基苏拉的治疗，并在剩下的研究中改用安慰剂。在TRAILBLAZER-ALZ 2研究中，66%的患者在一年内达到斑块清除率（基于上述标准）。

Kisunla can cause amyloid-related imaging abnormalities (ARIA), which is a potential side effect with amyloid plaque-targeting therapies that does not usually cause symptoms. It can be detected via magnetic resonance imaging (MRI) scans and, when it does occur, may present as temporary swelling in an area or areas of the brain, which usually resolves over time, or as small spots of bleeding in or on the surface of the brain.

Kisunla可引起淀粉样蛋白相关的影像异常（ARIA），这是淀粉样斑块靶向治疗的潜在副作用，通常不会引起症状。它可以通过磁共振成像（MRI）扫描来检测，当它确实发生时，可能表现为大脑某个或多个区域的暂时肿胀，通常会随着时间的推移而消退，或者表现为大脑表面或大脑表面的小出血点。

Infrequently, larger areas of bleeding in the brain can occur.8,15 ARIA can be serious, and life-threatening events can occur. Kisunla can also cause certain types of allergic reactions, some of which may be serious and life-threatening, that typically occur during infusion or within 30 minutes post-infusion.

很少发生大脑大面积出血。8,15 ARIA可能很严重，可能会发生危及生命的事件。Kisunla还可以引起某些类型的过敏反应，其中一些可能是严重的和危及生命的，通常在输注期间或输注后30分钟内发生。

Headache is another commonly reported side effect. See the Indication and Safety Summary with Warnings below for additional information. .

头痛是另一种常见的副作用。有关更多信息，请参阅下面带有警告的指示和安全摘要。。

About Kisunla™ (donanemab) Kisunla™ (donanemab-azbt) (pronounced kih-SUHN-lah) is an amyloid-targeting treatment for people with mild cognitive impairment (MCI) as well as people with mild dementia stage of early symptomatic Alzheimer's disease, with confirmed amyloid pathology. Kisunla can cause serious side effects, including amyloid-related imaging abnormalities, or ARIA, and infusion-related reactions.

关于Kisunla™（donanemab）Kisunla™（donanemab azbt）（发音为kih SUHN lah）是一种针对轻度认知障碍（MCI）患者以及早期症状性阿尔茨海默病轻度痴呆阶段患者的淀粉样蛋白靶向治疗，已证实淀粉样蛋白病理。Kisulla可引起严重的副作用，包括淀粉样蛋白相关的成像异常或ARIA，以及与输注相关的反应。

Kisunla is a prescription medicine administered intravenously every four weeks, 700 mg for the first three doses and 1400 mg thereafter.  .

Kisunla是一种处方药，每四周静脉注射一次，前三次服用700毫克，之后服用1400毫克。。

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 (MCI 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（MCI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 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 preventing 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，该试验旨在预防临床前AD患者的症状性阿尔茨海默病；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，其重点是通过新的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 more than 51 million 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Lilly Lilly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5100多万人。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；为一些最令人衰弱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。