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New Drugs for Diabetes may be approved in December 2017

2017-12-05 来源:转载自第三方
5 December 2017
  2017 is nearing the end, FDA has approved 40 new drugs in the previous 11 months, including Xadago (Newron) for Parkinson and Vosevi (Gilead) and Mavyret (Abbvie) for Hepatitis C, has already exceeded the total amount of 2016 year (22). However, there is no new drug for diabetes has been approved so far. According to FDA's PDUFA date, two new diabetes drugs are expected to be announced in December. Let's take a look.
  Semaglutide is a novel long-acting glucagon-like peptide-1 (GLP-1) analog developed by Novo Nordisk. GLP-1 is a hormone secreted by intestinal cells, which can promote insulin secretion, inhibit glucagon secretion, accelerate glucose metabolism, delay gastric emptying and suppress appetite. GLP-1 analogues can effectively help patients control blood sugar levels, while controlling body weight by suppressing appetite, to achieve double-edged sword effect. Similarly there is a DPP-4 inhibitor which inhibits the degradation of GLP-1 by inactivating DPP-4, thereby exerting a hypoglycemic effect.
  Semaglutide is administered subcutaneously once weekly, resulting in a substantial improvement in blood glucose levels in patients with type 2 diabetes and a lower risk of hypoglycaemia. In addition, semaglutide helps patients lose weight by reducing their appetite and reducing their food intake. Its hypoglycemic effect has been confirmed in clinical trials. A 40-week clinical trial evaluated the effect of semaglutide in combination with metformin and took dulaglutide as a control. The results showed that patients treated with semaglutide 0.5mg and 1.0mg, HbA1c decreased by 1.5% and 1.8%, respectively, were significantly better than dulaglutide. In addition, semaglutide also showed an advantage in helping patients lose weight: 44% and 63% of the two dose groups lost 5% of their body weight.
  The drug is being reviewed by several regulatory agencies around the world, including the U.S. FDA and the European Medicines Agency (EMA).
  Ertugliflozin is an oral, sodium-glucose cotransporter-2 (SGLT2) inhibitor developed by Pfizer for the treatment of type 2 diabetes. The main pharmacological mechanism of SGLT-2 inhibitors is to reduce tubular reabsorption of glucose by inhibiting SGLT-2, which is responsible for glucose reabsorption in the renal tubules, to allow more glucose to be excreted from the urine.
  Pfizer is seeking FDA’s approval for monotherapy as well as fixed-dose combinations with Merck's Januvia and metformin. In two pivotal phase III clinical studies (VERTIS MET, VERTIS SITA) announced in June this year, efficacy and safety of two doses of ertugliflozin (5mg and 15mg once daily) were evaluated as additional therapy to add to metformin or to the combination with either Merck DPP-4 inhibitor Januvia (sitagliptin). Ertugliflozin have made positive research data, both can significantly reduce HbA1c at 26th week.
  As new potential drugs for diabetes, we hope they will get FDA approval soon and expect more new and more effective drugs to bring new treatments to people with diabetes.
Edited by Suzhou Yacoo Science Co., Ltd.