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New member of SGLT-2 inhibitors, Ertugliflozin was approved by FDA!
2017-12-22
来源：转载自第三方
22 December 2017
On December 20, 2017, Merck and Pfizer's Steglatro (ertugliflozin) was approved by the FDA for approval for the treatment of type 2 diabetes in adults, becoming the second diabetes drug approved this year and the seventh approved SGLT-2 inhibitors. The combination preparations of Ertugliflozin/melbine (Segluromet) and Ertugliflozin/Sitagliptin (Steglujan) are also approved.
When the body can not produce enough insulin, or the sensitivity of insulin decreased, it will lose the normal ability of blood sugar regulation, suffering from type 2 diabetes. Type 2 diabetes, the most common type of diabetes in the world, is not so much a scary part of itself as it affects other parts of the body such as retinopathy, nephropathy, neurological disorders, and complications of coronary artery, cerebrovascular and peripheral vascular disease.
There are two subtypes of sodium-glucose cotransporter (SGLT)—SGLT-1 and SGLT-2. SGLT-2 inhibitor is the hottest target in recent years besides DPP-4 inhibitors. It was first discovered by Matthias Hanninger and his team at the University of Bern, and found to be specific in tubular cells. It blocks the reabsorption of glucose in the kidneys, excretes too much glucose through the urine, and lowers blood sugar levels. And the mechanism of action of SGLT-2 inhibitors does not depend on insulin. SGLT-2 inhibitors still exert their potent hypoglycemic effect when pancreatic β-cell function is impaired. Currently, a number of SGLT-2 inhibitors have been approved for marketing, including Canagliflozin, Dapagliflozin, Empagliflozin, Ipragliflozin L-Proline, Tofogliflozin Hydrate, Luseogliflozin. Ertugliflozin is the seventh listed SGLT-2 inhibitor.
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In the treatment of type 2 diabetes, Ertugliflozin conducted nine Phase III clinical trials involving approximately 12,600 patients with type 2 diabetes. Seven of these studies have been completed and data from the study showed that ertugliflozin significantly reduced glycosylated hemoglobin levels compared with placebo either with metformin or Januvia (sitagliptin). An unfinished clinical trial includes a phase III clinical trial to evaluate cardiovascular safety of Ertugliflozin, will be end on October 31, 2019.
Ertugliflozin is the seventh approved SGLT-2 inhibitor in the world and the fourth SGLT-2 inhibitor approved by the United States. It is currently under review of EMA. The new drug has excellent efficacy and safety, both as a monotherapy and as a combination therapy with other drugs. Next year, this new drug will officially enter the U.S. market and we expect it to bring better treatment options to patients!
Related links: The Mechanism and Common Drugs of DPP-4 Inhibitors
Edited by Suzhou Yacoo Science Co., Ltd.
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