– Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved finerenone (Kerendia™), a non-steroidal, selective mineralocorticoid receptor antagonist, for the treatment of adult patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%. Finerenone (10mg, 20mg, 40mg) is now indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with LVEF of ≥40%..

– 拜耳今天宣布，美国食品和药物管理局 (FDA) 已批准非甾体类选择性盐皮质激素受体拮抗剂 finerenone（Kerendia™），用于治疗心力衰竭（HF）且左心室射血分数（LVEF）≥40% 的成年患者。Finerenone（10mg、20mg、40mg）现在被指定用于降低 LVEF ≥40% 的成年心力衰竭患者的 cardiovascular 死亡风险、因心力衰竭住院以及紧急心力衰竭就诊的风险。

In March, the FDA granted Priority Review designation for the supplemental New Drug Application for finerenone for the treatment of adult patients with HF with an LVEF of ≥40%. The approval of finerenone by the FDA is based on the positive results of the pivotal Phase III FINEARTS-HF study, the results of which were presented at ESC Congress 2024, and simultaneously published in the .

今年3月，FDA授予了非奈利酮用于治疗LVEF≥40%的成人HF患者的补充新药申请优先审评资格。FDA对非奈利酮的批准是基于关键的III期FINEARTS-HF研究的积极结果，该结果在2024年ESC大会上公布，并同时发表在《》上。

New England Journal of Medicine

新英格兰医学杂志

. In FINEARTS-HF, finerenone achieved a statistically significant and clinically meaningful reduction of the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. These benefits were demonstrated regardless of background therapy, comorbidities, or hospitalization status.

在FINEARTS-HF研究中，非奈利酮在心血管死亡和总体（首次和复发）心衰事件的复合终点上取得了具有统计学意义且临床显著的降低，这些事件定义为因心衰住院或紧急心衰就诊。无论背景治疗、合并症或住院状态如何，均显示出这些益处。

The study is part of the ongoing MOONRAKER program, one of the largest Phase III clinical trial programs to date in heart failure, including over 15,000 patients, which aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings..

该研究是正在进行的MOONRAKER项目的一部分，这是迄今为止心力衰竭领域规模最大的III期临床试验项目之一，涵盖了超过15,000名患者，旨在广泛患者群体和临床环境中全面了解finerenone在心力衰竭中的作用。

“The FDA’s approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – a large and growing group of patients with a poor prognosis,” said Scott D. Solomon, MD, Professor of Medicine, Harvard Medical School, Director, Clinical Trials Outcomes Center, Mass General Brigham, and Chair of the study’s Executive Committee.

“FDA对非奈利酮的批准扩大了左心室射血分数≥40%的心力衰竭患者的治疗选择——这是一个预后较差且不断增长的患者群体，”哈佛医学院医学教授、Mass General Brigham临床试验结果中心主任、该研究执行委员会主席Scott D. Solomon博士表示。

“Based on the clinical efficacy we saw in the FINEARTS-HF study, finerenone can become a new pillar of comprehensive care, improve clinical outcomes and offer new hope to these patients in the U.S. with persistent high unmet medical needs.”.

“基于我们在FINEARTS-HF研究中看到的临床疗效，finerenone可以成为综合护理的新支柱，改善临床结果，并为美国这些存在持续高未满足医疗需求的患者提供新的希望。”

With this FDA approval, Kerendia is the only non-steroidal mineralocorticoid receptor (MR) antagonist approved in the U.S. for chronic kidney disease (CKD) associated with T2D and for HF with LVEF of ≥40%. Finerenone is a non-steroidal, selective MRA (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF and an LVEF of ≥40% in a Phase III study (FINEARTS-HF)..

随着这项FDA批准，Kerendia成为美国唯一获准用于与2型糖尿病（T2D）相关的慢性肾病（CKD）以及左心室射血分数（LVEF）≥40%的心力衰竭（HF）的非甾体类盐皮质激素受体（MR）拮抗剂。Finerenone是一种非甾体、选择性MRA（nsMRA），也是首个在III期研究（FINEARTS-HF）中证明对LVEF≥40%的心力衰竭患者具有心血管益处的针对盐皮质激素受体（MR）通路的药物。

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes.

通过针对MR和肾素-血管紧张素-醛固酮系统（RAAS）的过度激活，非奈利酮解决了射血分数≥40%的心衰关键方面，包括血流动力学因素以及炎症和纤维化过程。

“Building on our longstanding expertise in bringing innovative science to the cardiovascular space, today’s approval of finerenone in heart failure with a left ventricular ejection fraction of ≥40% marks an important milestone in Bayer’s commitment to improving the lives of patients with this condition.

“基于我们在心血管领域带来创新科学的长期专业知识，今天批准了非奈利酮用于左心室射血分数≥40%的心力衰竭，这标志着拜耳致力于改善这类患者生活的承诺中的一个重要里程碑。

While often balancing multiple comorbidities such as hypertension and atrial fibrillation, physicians have faced limited proven treatment options for these complex patients,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

“尽管常常需要平衡多种合并症，如高血压和心房颤动，但对于这些复杂的患者，医生面临的已证实治疗选择有限，”拜耳制药执行副总裁、全球产品战略与商业化主管兼医药品领导团队成员克里斯汀·罗斯说道。

“In the FINEARTS-HF study, finerenone reduced the occurrence of cardiovascular events in patients with this common form of heart failure, and we are excited about the potential of finerenone to emerge as a foundational therapy that can contribute to addressing patients’ tremendous needs.”.

“在FINEARTS-HF研究中，非奈利酮减少了这种常见类型心力衰竭患者的心血管事件发生率，我们对非奈利酮可能成为一种基础治疗的潜力感到兴奋，这将有助于满足患者的巨大需求。”

Approximately 3.7 million Americans live with HF LVEF ≥40%, which accounts for more than 500,000 hospitalizations per year. Most are balancing multiple comorbidities, such as diabetes, hypertension, obesity, and CKD, and they face high rates of hospitalization, leading to considerable mortality risk and significant strain on healthcare systems.

约 370 万美国人患有 HF LVEF ≥40%，这导致每年超过 50 万次住院。大多数患者同时面临多种合并症，如糖尿病、高血压、肥胖和慢性肾病 (CKD)，住院率居高不下，死亡风险显著，并给医疗系统带来沉重负担。

In patients with HF LVEF ≥40%, 25% are rehospitalized due to HF within 1 year of discharge, and the 5-year mortality rate is 75%..

在射血分数≥40%的心衰患者中，25%的患者在出院后1年内因心衰再次住院，5年死亡率为75%。

Finerenone is not currently approved in HF with an LVEF of ≥40% outside of the U.S. Finerenone has been submitted for marketing authorization in HF with an LVEF of ≥40% in China, the EU, and Japan, and these applications are currently under review. Further regulatory applications to health authorities in other markets worldwide have been filed or will follow..

目前，Finerenone在射血分数（LVEF）≥40%的心力衰竭（HF）患者中尚未在美国以外地区获得批准。Finerenone已在中国、欧盟和日本提交了针对LVEF≥40%的心力衰竭的上市授权申请，这些申请正在审查中。此外，针对其他全球市场的进一步监管申请已经提交或即将跟进。

Since 2021, Kerendia™ (finerenone, 10 mg or 20 mg) is approved in the U.S. for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure.

自2021年以来，Kerendia™（非奈利酮，10毫克或20毫克）在美国获批用于治疗与2型糖尿病（T2D）相关的慢性肾病（CKD）成人患者，以降低持续性估算肾小球滤过率（eGFR）下降、终末期肾病、心血管死亡、非致命性心肌梗死以及因心力衰竭住院的风险。

Based on the data from the FIDELIO-DKD and FIGARO-DKD trials, finerenone is approved for the treatment of adult patients with CKD associated with T2D in more than 95 countries worldwide, including in China, Europe, Japan, and the U.S., and recommended across multiple international guidelines as a pillar of therapy for improved kidney and cardiovascular outcomes in patients with CKD associated with T2D..

基于FIDELIO-DKD和FIGARO-DKD试验的数据，finerenone已在包括中国、欧洲、日本和美国在内的全球95多个国家获得批准，用于治疗与2型糖尿病相关的慢性肾脏病成人患者，并被多个国际指南推荐作为改善与2型糖尿病相关慢性肾脏病患者肾脏和心血管结局的治疗支柱。

About FINEARTS-HF

关于FINEARTS-HF

FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia™) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization.

FINEARTS-HF 是一项随机、双盲、安慰剂对照、多中心、事件驱动的 III 期研究，旨在评估 finerenone（Kerendia™）在预防心血管死亡和心力衰竭（HF）事件中的疗效与安全性。研究对象为诊断为有症状的心力衰竭（纽约心脏协会分级 II-IV 级）、左心室射血分数（LVEF）≥40% 的患者，该指标通过任何方法在过去 12 个月内测量，并且在随机分组前已接受至少 30 天的利尿剂治疗。

The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits..

FINEARTS-HF 的主要终点是心血管死亡和总体（首次和复发）心衰事件的复合终点，定义为因心衰住院或紧急心衰就诊。

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

大约6000名患者来自全球37个国家的630多个中心，随机接受每日一次非奈利酮或安慰剂治疗。此外，研究中的患者还接受了常规治疗以缓解症状和合并症。

With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings..

迄今为止，正在进行的包括FINEARTS-HF在内的finerenone相关MOONRAKER临床试验项目，已纳入总计超过15,000名患者，是规模最大的心衰研究项目之一，旨在全面了解finerenone在广泛患者群体和多样化临床环境中的应用。

About Kerendia

关于Kerendia

/ Firialta

/ 菲里阿尔塔

(finerenone)

（非奈利酮）

Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor (MR) antagonist that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors..

Kerendia™ 和 Firialta™ 是 finerenone 的全球保护商标。Finerenone 是一种非甾体类、选择性盐皮质激素受体（MR）拮抗剂，已被证明能够阻断 MR 过度激活的有害影响。MR 过度激活会导致慢性肾病（CKD）进展和心血管损伤，这些可能由代谢、血流动力学或炎症和纤维化因素驱动。

Finerenone is marketed as Kerendia™ or, in some countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 95 countries worldwide, including in China, Europe, Japan, and the U.S. In the U.S., finerenone is now approved under the brand name Kerendia for the treatment of heart failure and an LVEF of ≥40%..

Finerenone 以 Kerendia™ 或在某些国家以 Firialta™ 的名称上市，并已在包括中国、欧洲、日本和美国在内的全球 95 多个国家获批用于治疗与 2 型糖尿病（T2D）相关的慢性肾病（CKD）成年患者。在美国，finerenone 现已获批以 Kerendia 为品牌名，用于治疗心力衰竭且左心室射血分数（LVEF）≥40% 的患者。

The clinical study program with finerenone, FINEOVATE, currently comprises ten Phase III studies with dedicated programs in HF and CKD respectively. The MOONRAKER program includes FINEARTS-HF, as well as the ongoing collaborative, investigator-sponsored studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF.

芬尼酮的临床研究项目FINEOVATE目前包括十个三期研究，分别针对心衰（HF）和慢性肾病（CKD）的专门项目。MOONRAKER项目包括FINEARTS-HF，以及正在进行的合作性研究者发起的研究REDEFINE-HF、CONFIRMATION-HF和FINALITY-HF。

The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD and FIGARO-DKD, and the completed Phase II study CONFIDENCE, as well as the ongoing Phase III studies FIND-CKD, FIONA, FIONA-OLE, and FINE-ONE..

THUNDERBALL CKD项目包括已完成的III期研究FIDELIO-DKD和FIGARO-DKD，已完成的II期研究CONFIDENCE，以及正在进行的III期研究FIND-CKD、FIONA、FIONA-OLE和FINE-ONE。

About Heart Failure

关于心力衰竭

Heart failure is a complex clinical syndrome, characterized by a progressive decline in the heart’s ability to fill with and pump enough blood to meet the body’s needs for blood and oxygen. HF affects more than 60 million people worldwide and is the leading cause of hospitalization in people over 65.

心力衰竭是一种复杂的临床综合征，其特征是心脏充盈和泵出足够血液以满足身体对血液和氧气需求的能力逐渐下降。心力衰竭影响全球超过6000万人，并且是65岁以上人群住院的主要原因。

Prevalence of HF is projected to increase drastically over the next decade, partly as a consequence of the aging population. Patients with HF face a poor prognosis, with mortality rates similar to or worse than the most common cancers. HF can be complicated by several comorbidities, with more than half of patients living with conditions such as obesity, chronic kidney disease, diabetes mellitus, hypertension, and/or atrial fibrillation.

预计未来十年内，心力衰竭（HF）的患病率将急剧增加，部分原因是人口老龄化。心力衰竭患者面临较差的预后，其死亡率与最常见的癌症相似或更高。心力衰竭可能因多种合并症而复杂化，超过一半的患者同时患有肥胖、慢性肾病、糖尿病、高血压和/或心房颤动等疾病。

Symptoms of HF may include dizziness, shortness of breath, fatigue, sleep disturbance, chest discomfort, edema (swelling of feet and legs), and chronic coughing or wheezing..

心力衰竭的症状可能包括头晕、呼吸急促、疲劳、睡眠障碍、胸部不适、水肿（脚和腿的肿胀）以及慢性咳嗽或喘息。

Risk factors include hypertension, diabetes mellitus, smoking, a past myocardial infarction, and coronary artery disease. Despite advances in treatment, around 30% of people diagnosed with HF die within one year, increasing to around 40% after five years.

危险因素包括高血压、糖尿病、吸烟、既往心肌梗死和冠状动脉疾病。尽管治疗方法有所进展，但大约30%的心衰患者在确诊后一年内死亡，五年后这一比例上升至约40%。

When categorized by left ventricular ejection fraction (LVEF), which is a measure of cardiac function indicating how much blood the left ventricle pumps out with each contraction, HF is divided into three different categories:

根据左心室射血分数（LVEF）分类时，LVEF 是衡量心脏功能的指标，表示左心室每次收缩泵出的血液量，心力衰竭分为三种不同的类别：

·         Heart failure with reduced ejection fraction (HFrEF) is characterized by the compromised ability of the heart to eject oxygen-rich blood sufficiently during its contraction phase, where LVEF is ≤40%

· 射血分数降低的心力衰竭 (HFrEF) 的特征是心脏在收缩期无法充分泵出富氧血液，其左心室射血分数 (LVEF) ≤40%。

·         Heart failure with mildly reduced ejection fraction (HFmrEF) is a category of patients whose LVEF is between 41 to 49% and who have some impairment in the heart’s ability to pump

· 心力衰竭伴轻度降低射血分数（HFmrEF）是左心室射血分数（LVEF）在41%至49%之间且心脏泵血能力有部分受损的患者类别。

·         Heart failure with preserved ejection fraction (HFpEF) is a condition characterized by stiffness of the heart, leading to filling abnormalities as the left ventricle is unable to relax sufficiently to fill with blood, where LVEF is ≥50%

· 射血分数保留的心力衰竭 (HFpEF) 是一种以心脏僵硬为特征的疾病，由于左心室无法充分松弛以充满血液，导致充盈异常，其中左心室射血分数 (LVEF) ≥50%。

While LVEF ≤40% and LVEF ≥40% each account for approximately half of all HF cases, the burden of CV and non-CV comorbidities is higher in patients with LVEF ≥40%. Time trends also suggest that LVEF ≥40% will soon account for the majority of patients hospitalized with HF. While advances in therapy have been achieved in HF with LVEF ≤40%, there are limited guideline-directed treatment options for HF with LVEF ≥40%..

虽然LVEF ≤40%和LVEF ≥40%各占心衰病例的大约一半，但LVEF ≥40%的患者心血管和非心血管合并症的负担更高。时间趋势还表明，LVEF ≥40%将很快成为心衰住院患者的主体。尽管在LVEF ≤40%的心衰治疗中已取得进展，但针对LVEF ≥40%的心衰，遵循指南的治疗选择有限。

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

关于拜耳在心血管和肾脏疾病方面的承诺

Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth.

拜耳在心脏病学领域处于领先地位，并正在推进一系列创新治疗方案的组合。心脏和肾脏在健康和疾病中密切相关，拜耳正致力于开发针对心血管和肾脏疾病的新的治疗方法，以满足未被满足的医疗需求。其战略是通过将拜耳的产品组合转化为精准心脏病学，释放未来心血管市场的巨大潜力，应对高疾病负担，并推动长期增长。

Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated. .

拜耳的产品组合已经包括几种创新产品和化合物，处于临床前和临床开发的不同阶段。这些产品共同反映了公司的研究方法，即优先考虑有可能影响心血管疾病治疗方式的靶点和通路。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于推动可持续发展，并通过其业务产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。2024财年，集团拥有约93,000名员工，销售额达466亿欧元。