Liraglutide Injection (NovoRapid®) Receives NMPA Approval for Cardiovascular Indication in China
Novo Nordisk
Insulin Developer and Manufacturer
Beijing, May 14, 2020 /PRNewswire/ -- Today, the National Medical Products Administration (NMPA) approved Novo Nordisk's human glucagon-like peptide-1 (GLP-1) analog, Victoza®Marketing application for the cardiovascular indication of (liraglutide injection). The specific content of the approved indication is as follows: It is indicated to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adult patients with type 2 diabetes and established cardiovascular disease. As of May 14, Victoza®It is currently the only glucose-lowering drug in China with an indication for reducing cardiovascular risk.[1]。
Injury“Heart”of Diabetes: Cardiovascular Risk Becomes2# Major Health Threats for Type [X] Patients
Type 2 diabetes is a complex metabolic disorder characterized by hyperglycemia. Patients often present with macrovascular complications (such as cardiovascular, cerebrovascular, and lower extremity vascular diseases), microvascular complications (such as diabetic nephropathy and diabetic retinopathy), and other complications. Among these, cardiovascular disease is the leading cause of disability and mortality in patients with type 2 diabetes.[i]Globally, every 5 minutes, one person with diabetes has a heart attack.[ii]. Compared with the non-diabetic population, patients with diabetes have a 2- to 4-fold increased risk of developing cardiovascular and cerebrovascular diseases.[iii]. For patients with diabetes, one of the goals of blood glucose control is to reduce the risk of cardiovascular disease. According to data from the International Diabetes Federation (IDF), the number of people with diabetes in China exceeds 121 million.[iv], ranking first globally. Among them, patients with type 2 diabetes have a high incidence of cardiovascular risk factors but a low control rate.[v]. Therefore, when developing treatment plans for patients with diabetes, it is essential not only to focus on blood glucose levels but also to prioritize the patient's cardiovascular risk.
Balancing Glycemic Control and Cardiovascular Risk: Advancing Diabetes Management“Heart”Era
In the “2019 ESC/EASD Guidelines on Diabetes, Pre-Diabetes, and Cardiovascular Diseases,” the GLP-1 receptor agonist liraglutide is recommended as first-line therapy for patients with diabetes mellitus and established cardiovascular disease or at high cardiovascular risk, and it is further noted that the cardiovascular benefits of GLP-1 receptor agonists are more likely attributable to a reduction in atherosclerotic cardiovascular disease (ASCVD) events.[vi]。
As one of the most prominent GLP-1 receptor agonists, Victoza®is currently the only GLP-1 analog proven to reduce the risk of cardiovascular death[2]. Victoza®The cardiovascular benefits stem from its direct protective effects on the heart and blood vessels, leading to sustained improvement in atherosclerosis. The LEADER study, a multinational, multicenter, long-term cardiovascular outcomes trial[vii]Confirmed Victoza®Superior cardiovascular benefits can significantly reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Post-hoc analyses also suggest that Victoza®Possesses cardiovascular benefit mechanisms independent of statin therapy.
The results showed that, for patients with type 2 diabetes and cardiovascular disease, liraglutide significantly reduced the risk of major adverse cardiovascular events (MACE) by 13%, all-cause mortality by 15%, and cardiovascular death by 22% compared with placebo, when added to standard care. In this trial, the cardiovascular safety outcomes in the 92 Chinese participants were generally consistent with those observed in the overall study population.
Zhang Kezhou, Corporate Vice President of the Pharmaceutical Quality Department at Novo Nordisk China, stated, “Diabetes is prone to complications with cardiovascular disease, which severely impacts patients’ quality of life and can even be life-threatening. We place particular emphasis on the comorbidity management of type 2 diabetes and cardiovascular disease, aiming to help patients with type 2 diabetes reduce their risk of cardiovascular events and mortality by enhancing the cardiovascular benefits of glucose-lowering medications. Victoza®"Simultaneously addressing glycemic control and cardiovascular outcomes, it helps patients manage their disease more comprehensively."
Furthermore, Victoza®It can rapidly, efficiently, and sustainably lower glycated hemoglobin (HbA1c) while reducing the incidence of hypoglycemia, and better control multiple cardiovascular risk factors, including blood pressure, blood lipids, and body weight. This will effectively promote comprehensive disease management in patients with type 2 diabetes and bring greater benefits to patients.
Ms. Zhou Xiaping, Senior Vice President of Novo Nordisk and President of Greater China, stated: “NovoRapid®The approval of the cardiovascular indication is a landmark achievement for patients with type 2 diabetes in China. To date, it remains the only glucose-lowering medication in China approved for an indication to reduce the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and established cardiovascular disease.[3], Victoza®“This will significantly drive a shift in the philosophy of diabetes treatment, helping patients with type 2 diabetes improve their quality of life and reduce the risk of mortality. As a patient-centric company, we remain committed to addressing unmet patient needs, enhancing medication experience through innovation, and improving overall quality of life. In the future, we will continue to lead innovative breakthroughs in the field of diabetes, bringing revolutionary treatment solutions to Chinese doctors and patients, and continuing to contribute to ‘Transforming Diabetes Care in China.’”
Following the 2017 launch of Victoza®After being included in the National Reimbursement Drug List and entering the National Essential Medicines List in 2018, Victoza, by late 2019,®Successfully renewed its inclusion in the 2020-2021 National Reimbursement Drug List, with further expanded reimbursement coverage, continuing to benefit more Chinese patients with diabetes.
[1]As of May 14, 2020
[2]As of May 14, 2020
[3]As of May 14, 2020
[i]Chinese Diabetes Society, Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 Edition)
[ii]Statistics on Diabetes. American Diabetes Association Websitehttp://www.diabetes.org/diabetes-basics/statistics. Updated on March 22, 2018; accessed on April 20, 2018;
International Diabetes Federation. Diabetes and Cardiovascular Diseasehttps://www.idf.org/our-activities/care-prevention/cardiovascular-disease/cvd-report/10-diabetes-and-cardiovascular-disease-report.html, accessed on April 20, 2018
* Calculated based on the prevalence data in the United States published by the American Diabetes Association and the incidence rates published by the International Diabetes Federation
[iii]Chinese Diabetes Society, Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2017 Edition)
[iv]International Diabetes Federation. IDF Diabetes Atlas. 8th ed. Brussels, Belgium: International Diabetes Federation; 2017.
[v]Chinese Diabetes Society, Guidelines for the Prevention and Treatment of Type 2 Diabetes in China
[vi] Francesco,et al.European Heart Journal (2019) 00, 1-69. 2. Mach F, et al. Eur Heart J. 2019;ehz455. doi:10.1093/eurheartj/ehz455
[vii] Marso SP, et al.N Engl J Med. 2016 Jul 28;375(4)：311-22.