欧盟批准使诺和诺德的口服司美鲁肽成为首个也是唯一一个减少心血管死亡、心脏病发作和中风的口服GLP-1受体激动剂-动脉网

EU approval makes Novo Nordisk’s oral semaglutide the first and only oral GLP-1 RA to reduce cardiovascular death, heart attack and stroke

PHARMA FOCUS ASIA 等信源发布 2025-09-16 19:07

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Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Rybelsus® (oral semaglutide) label to reflect the cardiovascular benefits seen in the SOUL trial. SOUL was a phase 3b trial carried out to evaluate the effect of Rybelsus® on cardiovascular outcomes in people with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD)1.

诺和诺德今日宣布，欧洲药品管理局（EMA）人用药品委员会（CHMP）已批准更新Rybelsus®（口服司美鲁肽）的标签，以反映在SOUL试验中观察到的心血管益处。SOUL是一项3b期试验，旨在评估Rybelsus®对2型糖尿病以及动脉粥样硬化性心血管疾病（ASCVD）和/或慢性肾病（CKD）患者心血管结局的影响。

Rybelsus® is now the first and only oral glucagon-like peptide 1 receptor agonist (GLP-1 RA) – mimicking a natural hormone in your body that helps regulate blood sugar, appetite, and digestion – available in the EU for type 2 diabetes with a proven cardiovascular benefit1..

Rybelsus® 现已成为欧盟首个且唯一一款口服胰高血糖素样肽1受体激动剂（GLP-1 RA）——模拟体内一种帮助调节血糖、食欲和消化的天然激素——适用于2型糖尿病，并具有已证明的心血管益处。

“Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life – and this approval will help do just that,” said Emil Kongshøj Larsen, executive vice president, International Operations at Novo Nordisk.

“心脏病是2型糖尿病患者致残和死亡的主要原因。因此，能够同时解决心脏问题的治疗方案对于改善健康结果和生活质量至关重要——此次获批将有助于实现这一目标，”诺和诺德国际运营执行副总裁埃米尔·孔肖·拉森表示。

“This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits.”.

“这一里程碑使司美格鲁肽成为唯一一种具有经证实的血糖和体重降低以及心血管益处的口服GLP-1 RA。”

New results from the SOUL trial will be shared later this week at the European Association for the Study of Diabetes (EASD) 2025 Annual Meeting, 15–19 September. These include findings that treatment with oral semaglutide significantly reduced hospitalisations related to serious adverse events compared with placebo2.

SOUL试验的新结果将在本周晚些时候于2025年9月15日至19日举行的欧洲糖尿病研究协会（EASD）年会上分享。这些结果包括：与安慰剂相比，口服司美鲁肽治疗显著减少了与严重不良事件相关的住院人数。

Additional SOUL results will be presented at the same meeting, which highlight that the cardiovascular benefits of oral semaglutide were consistent regardless of body mass index (BMI) and body weight of participants3..

将在同一会议上展示更多的SOUL研究结果，这些结果强调了口服司美格鲁肽的心血管益处无论参与者的体重指数（BMI）和体重如何都是一致的。

In the US, a decision is expected later this year for a label extension for the cardiovascular indication for Rybelsus®. Novo Nordisk has also submitted an application in the US for a once-daily 25 mg oral formulation of semaglutide (Wegovy® in a pill) in adults living with obesity or overweight and cardiovascular disease.

在美国，预计今年晚些时候将做出关于Rybelsus®心血管适应症标签扩展的决定。诺和诺德还向美国提交了一份申请，针对每日一次25毫克口服司美鲁肽（Wegovy®药丸）用于患有肥胖或超重以及心血管疾病的成人患者。

A decision is expected at the turn of this year, and if approved, Wegovy® would become the first oral GLP-1 RA indicated for chronic weight management..

预计将在今年年底做出决定，如果获得批准，Wegovy® 将成为首个用于慢性体重管理的口服 GLP-1 RA。

Rybelsus® is the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes, following its launch in 2019. It is supported by a strong clinical and real-world evidence base, demonstrating superior blood glucose reduction and body weight reduction versus multiple comparators, as well as an established safety profile in people with type 2 diabetes4-8..

Rybelsus® 是首个也是唯一一个在2019年推出后被批准用于治疗2型糖尿病的口服GLP-1 RA。它有着强大的临床和真实世界证据基础，证明与多种对照药物相比，在降低血糖和体重方面表现更优，同时在2型糖尿病患者中展现了既定的安全性4-8。

About SOUL

关于SOUL

SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial, with 9,650 participants enrolled. It was conducted to assess the effect of oral semaglutide versus placebo, when added to standard of care, on cardiovascular outcomes in people with type 2 diabetes and established cardiovascular disease and/or chronic kidney disease (CKD).

SOUL 是一项多中心、国际、随机、双盲、平行组、安慰剂对照的 3 期心血管结局试验，共纳入了 9,650 名参与者。该研究旨在评估口服司美鲁肽与安慰剂在加入标准治疗后，对患有 2 型糖尿病且已确诊心血管疾病和/或慢性肾病（CKD）患者的心血管结局的影响。

The SOUL trial was initiated in 2019. The primary outcome was time-to-first occurrence of major adverse cardiovascular events (MACE; a composite objective consisting of cardiovascular death, heart attack and stroke) 1..

SOUL试验于2019年启动。主要终点是主要不良心血管事件（MACE；包括心血管死亡、心脏病发作和中风的复合指标）首次发生的时间。

The SOUL trial demonstrated a superior reduction in MACE of 14% for people treated with oral semaglutide compared to placebo in people with type 2 diabetes and cardiovascular disease and/or CKD, making Rybelsus® (oral semaglutide) the first and only oral GLP-1 RA with a proven cardiovascular benefit1..

SOUL试验表明，与安慰剂相比，口服司美格鲁肽治疗2型糖尿病和心血管疾病及/或慢性肾病患者时，主要不良心血管事件（MACE）显著减少了14%，这使得Rybelsus®（口服司美格鲁肽）成为首个且唯一具有经证实的心血管益处的口服GLP-1受体激动剂。

About Rybelsus®

关于Rybelsus®

Rybelsus® (oral semaglutide) is a glucagon-like peptide 1 receptor agonist (GLP-1 RA) indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise7, 9. Rybelsus® is administered once daily and is approved for use in the following therapeutic dosages: 1.5 mg, 3 mg, 4 mg, 7 mg, 9 mg, 14 mg, 25 mg and 50 mg4, 5.

Rybelsus®（口服司美鲁肽）是一种胰高血糖素样肽1受体激动剂（GLP-1 RA），适用于治疗成人2型糖尿病患者，当饮食和运动控制不足时，可作为辅助治疗以改善血糖控制。Rybelsus®每日一次口服使用，获批的治疗剂量包括：1.5毫克、3毫克、4毫克、7毫克、9毫克、14毫克、25毫克和50毫克。

Rybelsus® offers superior blood glucose lowering versus multiple comparators4, 5, together with consistent weight reduction4, 5, 10, reduction in cardiometabolic risk factors10 and reduction in major adverse cardiovascular events (MACE) 1. Rybelsus® is now the first and only oral GLP-1 RA available in the EU for type 2 diabetes with a proven cardiovascular benefit1.

Rybelsus® 在降低血糖方面相较于多种对照药物表现出更优的效果4, 5，同时还能持续减轻体重4, 5, 10，减少心代谢风险因素10，并降低主要不良心血管事件（MACE）1。Rybelsus® 现在是欧盟首个也是唯一一款针对 2 型糖尿病并具有已证明心血管益处的口服 GLP-1 受体激动剂1。

It is currently available in 48 countries11, and more than 2.4 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide12..

目前，它已在48个国家/地区上市11，全球已有超过240万名2型糖尿病患者正在接受Rybelsus®治疗12。

About Wegovy®

关于Wegovy®

Semaglutide 2.4 mg is marketed under the brand name Wegovy®. In the EU, Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m2 or greater (obesity) or adults with a BMI of 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.

司美格鲁肽2.4毫克以品牌名Wegovy®上市。在欧盟，Wegovy®被指定用于配合低热量饮食和增加体力活动，用于管理BMI≥30 kg/m²（肥胖）或BMI≥27 kg/m²（超重）且至少有一种与体重相关的合并症的成年人的体重。

In the EU, Wegovy® is also indicated for paediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy® major adverse cardiovascular events (MACE) risk reduction, improvements in heart failure with preserved ejection fraction (HFpEF)-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis13..

在欧盟，Wegovy® 还适用于 12 岁及以上初始 BMI 达到或超过同年龄和性别第 95 百分位数（肥胖）且体重超过 60 公斤的儿科患者。标签的临床部分还包括 Wegovy® 在主要不良心血管事件 (MACE) 风险降低、射血分数保留型心力衰竭 (HFpEF) 相关症状和身体功能改善以及膝关节骨关节炎相关疼痛减轻方面的数据。

In the US, Wegovy® is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of MACE in adults with established cardiovascular disease and either obesity or overweight, to reduce excess body weight and maintain weight reduction long term in paediatric patients aged 12 years and older with obesity and in adults with obesity or with overweight in the presence of at least one weight-related comorbid condition, as well as for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver, in combination with a reduced calorie diet and increased physical activity14..

在美国，Wegovy® 适用于与减少热量饮食和增加体力活动联合使用，以降低已确诊心血管疾病且伴有肥胖或超重的成年人发生主要不良心血管事件 (MACE) 的风险；用于减少 12 岁及以上肥胖儿科患者以及伴有至少一种与体重相关合并症的肥胖或超重成年患者的过多体重并长期维持减重效果；同时也用于治疗患有中度至重度肝纤维化（但非肝硬化）的非肝硬化代谢功能障碍相关脂肪性肝炎 (MASH) 成年患者，配合减少热量饮食和增加体力活动使用。

Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.

诺和诺德是一家全球领先的医疗保健公司，成立于1923年，总部位于丹麦。我们的宗旨是基于我们在糖尿病领域的传统，推动变革以战胜严重的慢性疾病。我们通过开创科学突破、扩大药品的可及性，并努力预防和最终治愈疾病来实现这一目标。

Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube..

诺和诺德在80个国家拥有约78,400名员工，并在大约170个国家销售其产品。欲了解更多信息，请访问novonordisk.com、Facebook、Instagram、X、LinkedIn和YouTube。

Contacts for further information

更多信息请联系

Media:

媒体：

Ambre James-Brown

安布尔·詹姆斯-布朗

+45 3079 9289

globalmedia@novonordisk.com

globalmedia@诺和诺德.com

Liz Skrbkova (US)

莉兹·斯克尔科娃（美国）