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GLP-1 antidiabetic drugs semaglutide will soon be listed in Japan
2017-03-08
来源：转载自第三方
8 March 2017
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Recently, Novo Nordisk announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for semaglutide, a new hypoglycemic drug semaglutide in its official website. The drug is a new long-acting GLP-1 analogue that can significantly improve blood glucose levels in patients with type 2 diabetes and a low risk of hypoglycemia. At the same time, it can induce weight loss and reduce the incidence of major cardiovascular events.
The latest data from the International Diabetes Federation (IDF) show that in 2014 there were 387 million people with diabetes around the world, of which, type 2 diabetes accounted for 85% to 95% in high-income countries. At present, more than 450 million people worldwide suffer from diabetes, and it is estimated that by 2035, the number of diabetic patients will increase by 55% to 600 million. In recent years, the number of diabetic patients in China was a blowout growth, according to the 2010 "New England Medical Journal", the prevalence of diabetes in adults in China was 9.7%, pre-prevalence rate is up to 15.5%.
Among the hypoglycemic drugs, glucagon-like peptide-1 (GLP-1) analogue and DPP-4 inhibitors are the best and the side effects are minimal. GLP-1 is a hormone secreted by small intestinal cells, can promote insulin secretion after eating, inhibit glucagon secretion, speed up glucose metabolism, delay gastric emptying, inhibition of appetite. GLP-1 analogues can help patients control blood sugar levels, while suppressing appetite and controlling weight, to achieve the effect of double-edged sword. DPP-4 inhibitors such as vildagliptin (intermediate 3-amino-1-Adamantanol) and linagliptin (intermediate 3,7-dihydro-3-methyl-1H-purine-6-diketone), the hypoglycemic mechanism is similar to that of GLP-1 analogues—inhibition of GLP-1 degradation by inactivating DPP-4, resulting in hypoglycemic effects while not causing weight loss influences.
Obesity is an independent risk factor for diabetes, is due to energy intake and energy consumption imbalance caused by excessive accumulation of lipid in the body, it has become a worldwide problem, so that the World Health Organization named the phenomenon of spread as the "globesity". On the other hand, diabetes can also increase the risk of heart disease, stroke and other diseases, and cardiovascular complications will also significantly affect the health of patients with diabetes and life expectancy. It is estimated that around the world, about 50% of type 2 diabetes deaths are caused by cardiovascular disease. Therefore, treatment drugs for diabetes have been placed to hope to reduce the risk of cardiovascular complications in patients.
Semaglutide included six phase III clinical trials to investigate the efficacy and safety of semaglutide (once weekly) combined with oral hypoglycemic agents and basal insulin. According to clinical data:
In reducing and maintaining the blood sugar and blood sugar control, the effect of semaglutide was significantly better than the previous drug;
Semaglutide showed effect reducing weight in clinical trials, which can make patients with type 2 diabetes better manage their own condition;
In clinical studies of large cardiovascular prognosis, semaglutide significantly reduced the risk of major cardiovascular events in patients with type 2 diabetes mellitus;
In terms of safety, semaglutide has good tolerance and safety, the most common adverse events are nausea.
Semaglutide showed effect reducing weight in clinical trials, which can make patients with type 2 diabetes better manage their own condition;
In clinical studies of large cardiovascular prognosis, semaglutide significantly reduced the risk of major cardiovascular events in patients with type 2 diabetes mellitus;
In terms of safety, semaglutide has good tolerance and safety, the most common adverse events are nausea.
The prospects of semaglutide are very promising, at the end of last year, it has been submitted to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and SwissMedic, and submitted an application in Japan this year, it has a trend of comprehensive listing. The drug is not only easy to use, only a weekly injection can effectively improve blood sugar levels, and can induce weight loss and reduce major cardiovascular events. Semaglutide not only brings the gospel to the type 2 diabetes patients, but also will help Novo Nordisk maintain the dominant position in the global diabetes market.
Edited by the Editorial Office of Suzhou Yacoo Science Co., Ltd.
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