诺和诺德向FDA及EMA提交liraglutide监管文件

诺和诺德（Novo Nordisk）12月20日宣布，已分别向美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）提交了高剂量利拉鲁肽（liraglutide，3mg）的新药申请（NDA）和上市许可申请（MAA）。

liraglutide是一种每日一次的人胰高糖素样肽-1（GLP-1）类似物，作为低热量饮食和增加体力活动的辅助药物，用于肥胖症或超重合并症成人患者的体重管理。

liraglutide（3mg）监管申请文件的数据，包括III期SCALE临床项目和早期开发数据以及liraglutide用于2型糖尿病治疗的数据。

SCALE临床项目包括4个III期临床试验，涉及超过5000例肥胖症患者（ BMI≥ 30 kg/m2），研究中liraglutide结合饮食和运动，诱导并维持了减肥效果，同时也显著改善了肥胖相关合并症，如高血压、血脂异常、睡眠呼吸暂停。此外，在肥胖症合并2型糖尿病或糖尿病前期（prediabetes）患者中，除了降低体重外，liraglutide（3mg）也显著改善了血糖控制。

关于利拉鲁肽（liraglutide）：

liraglutide是新一代的人胰高血糖素样肽-1（GLP-1）类似物，具有葡萄糖浓度依赖性的降糖效应和β细胞保护作用，每日只需皮下注射1次，即可持续发挥作用而起到良好的降糖效果，单独使用很少引起低血糖，同时还具备多种降糖外效应：如减轻患者体重，调节血压、血脂等心血管危险因素。

英文原文：Novo Nordisk files for regulatory approval of liraglutide 3 mg for the treatment of obesity

Bagsvaerd, Denmark, Dec. 20, 2013 (GLOBE NEWSWIRE) -- Bagsvaerd, Denmark, 20 December 2013 - Novo Nordisk today announced two separate regulatory submissions for a 3 mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight with comorbidities. The company filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA).

The submissions for liraglutide 3 mg include data from the Phase 3 SCALE™ clinical trial  programme, which involved more than 5,000 people with obesity (BMI ≥30 kg/m2 ), or  who are overweight (BMI ≥27 kg/m2 ) with comorbidities. In addition to the data from the  SCALE™ programme, data from earlier development phases and data related to the use  of liraglutide in type 2 diabetes were also included in the submissions. 

Data from the SCALE™  clinical trial programme have consistently demonstrated that  liraglutide 3 mg, in combination with diet and exercise, induces and maintains weight  loss, while also significantly improving obesity-related comorbidities such as  hypertension, dyslipidaemia and sleep apnoea. Furthermore, in people with obesity and  type 2 diabetes or prediabetes, trials have demonstrated that liraglutide 3 mg  significantly improves glycaemic control, in addition to lowering weight.   
“We believe that liraglutide 3 mg has the potential to make a significant difference in the  management of obesity by providing both a sustainable weight loss and an improvement  in several obesity-related comorbidities”, said Mads Krogsgaard Thomsen, executive vice  president and chief science officer of Novo Nordisk.

About obesity

Obesity is a disease1  that requires chronic management. It is often linked to serious  comorbidities – including type 2 diabetes, heart disease, obstructive sleep apnoea and  certain types of cancer – accompanied by a decreased life expectancy of 5–10 years. The  risk of morbidity and mortality increases with the severity of obesity. It is a complex and multifactorial disease, influenced by genetic, physiological, environmental and  psychological factors.  
The global increase in the prevalence of obesity is a public health issue with huge cost  implications to healthcare systems. In the US, approximately 35% of adults, or some 100  million people are obese. A sustained weight loss of 5–10% has been shown to be  associated with significant health benefits. 

About the SCALE™ clinical programme

SCALE™ (Satiety and Clinical Adiposity – Liraglutide Evidence in Non-diabetic and  Diabetic people) consists of four trials encompassing more than 5,000 people who are  overweight (BMI ≥27 kg/m2 ) and with comorbidities such as hypertension, dyslipidaemia,  or type 2 diabetes, or who have obesity (BMI ≥30 kg/m2 ) with or without comorbidities.  In addition to demonstrating safety and efficacy for weight management with liraglutide  3 mg, each of the four trials had a specific focus: 
SCALE™ Obesity and Prediabetes2  (3,731 people randomised) – a 56-week and 160-week  randomised, placebo-controlled trial in people with obesity, or overweight people with  comorbidities, designed to demonstrate clinically meaningful and safe weight loss after  56 weeks of treatment with liraglutide 3 mg. The 56-week results were reported in May  2013. The 160-week extension study is ongoing and investigates the long-term effect of  liraglutide 3 mg, in combination with diet and exercise, on the progression to type 2  diabetes. 

SCALE™ Maintenance3  (422 people randomised) – a 56-week randomised, placebo-controlled trial designed to show maintenance of weight loss in people with obesity or overweight people with comorbidities, who have successfully achieved a 5% or greater  weight loss during a three-month run-in period that included a lifestyle intervention  programme of low-calorie diet and exercise alone. The results of SCALE™ Maintenance  were reported in 2010.     SCALE™ Diabetes4  (846 people randomised) – a 56-week randomised, placebo-controlled  trial designed to demonstrate clinically meaningful and safe weight loss with liraglutide 3 mg in people with obesity, or overweight people with type 2 diabetes. The results of  SCALE™ Diabetes were reported in March 2013. 

SCALE™ Sleep Apnoea5  (359 people randomised) – a 32-week randomised, double-blind,  placebo-controlled trial in people with obesity with moderate or severe obstructive sleep  apnoea (OSA) to investigate the effect of liraglutide 3 mg, in combination with diet and  exercise, in reducing the severity of OSA. The results of SCALE™ Sleep Apnoea were  reported in August 2013.