FDA接受口服司美鲁肽25毫克的申请，或成首个用于治疗肥胖症的口服GLP-1药物-动脉网

FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity

CISION 等信源发布 2025-05-03 02:27

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可切换为仅中文

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Novo Nordisk hopes to expand Wegovy

诺和诺德希望扩大Wegovy的使用范围

label by becoming the first

标签成为第一

GLP-1

treatment for obesity in a pill

肥胖症的药丸治疗

The FDA filing is based on the results of the phase 3 OASIS 4 trial that evaluated oral semaglutide 25 mg in adults with obesity or overweight

FDA 的申请基于 3 期 OASIS 4 试验的结果，该试验评估了口服司美鲁肽 25 毫克在肥胖或超重成人中的效果。

Novo Nordisk continues to build on 100-year-plus legacy of science and innovation

诺和诺德继续构建其超过百年的科学与创新传统

PLAINSBORO, N.J.

普兰斯伯勒，新泽西州

，

May 2, 2025

2025年5月2日

/PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy

/PRNewswire/ -- 诺和诺德公司今天宣布，美国食品药物管理局（FDA）已接受其每日一次、25毫克口服制剂的Wegovy新药申请（NDA）。

(semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.

（司美格鲁肽）用于治疗生活中的肥胖症或超重并伴有至少一种合并症的成年患者的慢性体重管理，并降低超重或肥胖且患有已确诊心血管疾病的成年人发生主要不良心血管事件（MACE）的风险。

If approved, Wegovy

如果获得批准，Wegovy

would become the first oral formulation of a

将成为首个口服制剂的

GLP-1

indicated for chronic weight management.

适用于慢性体重管理。

'We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations,' said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc. 'Novo Nordisk's strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment.

“我们正在进入肥胖症治疗的新时代，患者希望获得满足他们需求并提供选择的个性化治疗方案，包括口服制剂，”诺和诺德公司临床开发、医学与监管事务高级副总裁安娜·温德尔博士表示。“诺和诺德在肥胖症治疗领域的深厚积淀以及数十年的科学研究和创新使我们走到了今天。”

We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral .

我们很高兴FDA接受了我们的申请，并期待与监管机构合作，这将是第一个口服的。

GLP-1

treatment for obesity.'

肥胖症的治疗。

The FDA application is based on results from OASIS 4, a 64-week phase 3 randomized, controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI >/= 30 kg/m

FDA 的申请基于 OASIS 4 的结果，这是一项为期 64 周的 3 期随机对照试验，评估了每日一次口服司美鲁肽 25 毫克与安慰剂在 307 名肥胖（BMI ≥ 30 kg/m²）成人中的疗效和安全性。

) or overweight (BMI >/= 27 kg/m

）或超重（BMI ≥ 27 kg/m

) with one or more comorbidities.

）伴有一种或多种合并症。

1,3

Patients with diabetes were excluded.

糖尿病患者被排除在外。

1,3

OASIS 4 included a 64-week treatment period including a 12-week dose escalation, and a 7-week off-treatment follow-up period.

OASIS 4 包括一个 64 周的治疗期，其中包括 12 周的剂量递增期，以及一个 7 周的非治疗随访期。

1,3

In total, 307 participants were randomized 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, as an adjunct to lifestyle intervention for 64 weeks.

总共有307名参与者以2:1的比例随机分配至每日一次口服司美鲁肽25 mg或安慰剂组，作为生活方式干预的辅助手段，持续64周。

1,3

The FDA action date to decide on the Wegovy

FDA对Wegovy作出决定的行动日期

oral formulation NDA will be in Q4 2025.

口服制剂的新药申请（NDA）将在2025年第四季度提交。

About Wegovy

关于Wegovy

Wegovy

韦哥维

(semaglutide) injection 2.4 mg is currently approved along with a reduced calorie diet and increased physical activity, for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off and to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight..

司美格鲁肽注射液2.4 mg 目前已获批与减少热量饮食和增加体力活动联合使用，适用于12岁及以上患有肥胖症的成人和儿童，或部分同时伴有体重相关健康问题的超重成人，帮助他们减去多余体重并保持减重效果，并降低已知患有心脏病且伴有肥胖或超重的成人发生主要心血管事件（如死亡、心脏病发作或中风）的风险。

About obesity

关于肥胖症

Obesity is a serious chronic, progressive, and misunderstood disease that requires long-term management.

肥胖是一种严重的、慢性的、进行性的且常被误解的疾病，需要长期管理。

5-7

One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.

一个关键的误解是，这只是一种缺乏意志力的疾病，而事实上，存在可能阻碍肥胖者减肥并保持体重的潜在生物学因素。

5,7

Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.

肥胖受到多种因素的影响，包括遗传、健康的社会决定因素和环境。

8,9

The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.

超重和肥胖的普遍性是一个公共卫生问题，对医疗系统有严重的成本影响。

10,11

10，11

In the U.S., about 40% of adults live with obesity.

在美国，大约有 40% 的成年人患有肥胖症。

About Novo Nordisk

关于诺和诺德

Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders.

诺和诺德是一家全球领先的医疗保健公司，一百多年来一直致力于研发创新药物，帮助糖尿病患者过上更长寿、更健康的生活。这一历史传承赋予了我们经验和能力，也使我们能够推动变革，帮助人们战胜其他严重的慢性疾病，如肥胖症、罕见血液病和内分泌紊乱。

We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. .

我们始终坚信，持久成功的秘诀在于保持专注、着眼长远，并以财务、社会和环境负责任的方式经营业务。

With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit

诺和诺德美国公司在美国已有40年的历史，总部位于新泽西州，在全美八州及华盛顿特区的12个制造、研发和企业地点拥有超过10,000名员工。欲了解更多信息，请访问

novonordisk-us.com

诺和诺德美国官网

，

Facebook

，

Instagram

图享

, and

，以及

。

Contacts for further information

更多信息请联系

Media:

媒体：

Liz Skrbkova

莉兹·斯克尔科娃

(

美国

)

+1 609 917 0632

NNIMediaTeam@novonordisk.com

诺和诺德媒体团队@novonordisk.com

Ambre James-Brown (Global)

安伯·詹姆斯-布朗（全球）

+45 3079 9289

Globalmedia@novonordisk.com

全球媒体@诺和诺德.com

Investors:

投资者：

Frederik Taylor Pitter (US)

弗雷德里克·泰勒·皮特（美国）

+1 609 613 0568

fptr@novonordisk.com

fptr@诺和诺德.com

Jacob Martin Wiborg Rode (Global)

雅各布·马丁·维博格·罗德（全球）

+45 3075 5956

jrde@novonordisk.com

jrde@诺和诺德.com

Sina Meyer (Global)

新浪迈耶（全球）

+45 3079 6656

azey@novonordisk.com

azey@诺和诺德.com

Ida Schaap Melvold (Global)

伊达·沙普·梅尔沃尔德（全球）

+45 3077 5649

idmg@novonordisk.com

idmg@诺和诺德.com

Max Ung (Global)

马克斯·昂（全球）

+45 3077 6414

mxun

@novonordisk.com

@诺和诺德.com

References

参考文献

Garvey W, Duque do Vale R, Karlsson T, et al. Efficacy and Safety of Oral Semaglutide 25 mg in Adults With Overweight/Obesity: The OASIS 4 RCT. Oral presentation presented at ObesityWeek

Garvey W、Duque do Vale R、Karlsson T 等。口服司美鲁肽25毫克在成年超重/肥胖患者中的疗效与安全性：OASIS 4 随机对照试验。在肥胖周（ObesityWeek）上的口头报告。

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2024；

3-6 November 2024

2024年11月3日至6日

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；亨利·B·冈萨雷斯会议中心，

San Antonio

圣安东尼奥

, US. Presentation Oral-108.

，美国。口头报告-108。

Oral Semaglutide 25 mg FDA NDA filing; Novo Nordisk data on file.

口服司美格鲁肽25 mg FDA新药申请提交；诺和诺德数据存档。

ClinicalTrials.Gov. Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Works in People Who Have a Body Weight Above the Healthy Range (OASIS 4). Last accessed:

ClinicalTrials.Gov。研究每日一次口服司美鲁肽片在体重高于健康范围的人群中的疗效（OASIS 4）。最后访问时间：

May 2025

2025年5月

. Available at:

. 可在以下位置获取：

https://clinicaltrials.gov/study/NCT05564117

。

Wegovy

诺和盈

(semaglutide) injection 2.4 mg Prescribing Information.

（司美格鲁肽）注射液 2.4 mg 处方信息。

Plainsboro, NJ

新泽西州普兰斯堡

: Novo Nordisk Inc.; 2025.

：诺和诺德公司；2025年。

Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study.

卡普兰 LM，戈尔登 A，金内特 K 等。对有效肥胖护理障碍的认知：来自全国行动研究的结果。

Obesity

肥胖症

. 2018;26(1):61-69.

Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation.

布雷 GA，金 KK，威尔丁 JPH；世界肥胖联合会。肥胖：一种慢性复发性进行性疾病过程。世界肥胖联合会的立场声明。

Rev

修订版

. 2017;18(7):715-723.

Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity.

加维WT，梅查尼克JI，布雷特EM等。美国临床内分泌医师协会和美国内分泌学院为肥胖患者医疗护理制定的综合临床实践指南。

Endocr Pract

内分泌实践

. 2016;22 (Suppl 3):1-203.

. 2016;22 (增刊3):1-203.

Centers for Disease Control and Prevention. Adult obesity facts. Last accessed:

疾病控制和预防中心。成人肥胖事实。最后访问：

May 2025

2025年5月

. Available at:

。可从以下地址获取：

https://www.cdc.gov/obesity/adult-obesity-facts/index.html