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Two New Diabetes Drug Combinations Get Approvals from FDA

2016-11-24 来源:转载自第三方
24 November 2016
   Recently, the new type of diabetes drug combination, Soliqua 100/33 from French pharmaceutical companies Sanofi and Xultophy 100/3.6 from Danish pharmaceutical companies Novo Nordisk received FDA’s approval. These two drugs are daily injections of combination of long-acting insulin and glucagon-like peptide-1 (GLP-1) analogues, for the use of patients can not effectively control blood glucose by insulin alone or GLP-1 analogues.
   At present, there are more than 450 million people worldwide suffering from diabetes, it kills 6 people per second. By 2025, 75% diabetic patients will be concentrated in developing countries; by 2040, there are about 642 million patients worldwide. Among this, type II diabetes accounted for the vast majority. Type II diabetes occurs mainly in adults, the pathogenic factors is unhealthy lifestyle, including obesity, lack of exercise, high fat and high sugar diet and so on.
   Some patients of type II diabetes have insulin resistance, the body still has insulin close to the normal level, but the body can not make the right response to insulin, making the blood sugar increase. Early symptoms is not obvious, only mild fatigue, thirst, often can occur in large vessels and microvascular complications before the diagnosis. For patients, the simple use of insulin can not play a very good effect, need to use other hypoglycemic drugs to achieve the purpose of controlling blood sugar.
   Among the numerous hypoglycemic agents, GLP-1 analogs and DPP-4 inhibitors are the most effective ones and have the least side effects. GLP-1 is a hormone secreted by small intestinal cells, which can promote insulin secretion, inhibit glucagon secretion, accelerate glucose metabolism, delay gastric emptying and suppress appetite. GLP-1 analogue can effectively help patients control blood glucose levels, and control weight by suppressing appetite. DPP-4 inhibitors, such as vildagliptin (intermediate 3-amino-1-adamantanol) and ligagliptin (intermediate 3,7-dihydro-3-methyl-1H-purine-6-dione), the mechanism of hypoglycemic action is similar to that of GLP-1 analogues——by inactivating DPP-4 to inhibit the degradation of GLP-1, thereby acting as a hypoglycemic agent, and there is no influences on weight.
   Soliqua 100/33 is a combination of the long-acting insulin “insulin glargine“ and the GLP-1 analog ”lixisenatide“, the drugs are pre-filled into the pen at doses ranging from 15 to 60 units of insulin and 5 to 20 micrograms of lixisenatide, once a day is needed. In Phase 3 clinical trials, the Soliqua 100/33 reduced HbA1c levels below a target of 7% for 55% users.
   injection pen
   Xultophy 100/3.6 is combination of a long-acting insulin “insulin degludec” and GLP-1 analogue “liraglutide”. It is also prefilled in disposable injection pens at doses ranging from 16 to 50 units of insulin and 0.58 to 1.8 mg of liraglutide for once a day. In Phase 3 clinical trials, Xultophy 100/3.6 successfully reduced HbA1c levels by 1.67% and 1.94%.
   Sanofi and Novo Nordisk are committed to the development of new drugs for diabetes. The combination new drugs of insulin and GLP-1 analogs are in injection pens, and have a variety of dosage types to choose, it is also easy to use. Both new drugs are expected to be available in the US in early 2017, They provide new options for patients with uncontrolled blood glucose with a single drug.
Related link: 3-amino-1-adamantanol
Edited by the Editorial Office of Suzhou Yacoo Science Co., Ltd.