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FDA approves once-daily Qtern for type-2 diabetes
FDA approves once-daily Qtern for type-2 diabetes.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 0243Y AstraZeneca PLC 28 February 2017 \n\nThis announcement contains inside information\n \n28 February 2017 07:00 GMT\n \nFDA APPROVES ONCE-DAILY QTERN (DAPAGLIFLOZIN AND SAXAGLIPTIN) TABLETS FOR ADULTS WITH TYPE-2 DIABETES \n \nQtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar level\n \nAstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycaemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.\n \nElisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca, said: \"Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone. The approval of Qtern is good news for patients who may benefit from improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet.\" \n \nSGLT-2 inhibitors help patients achieve improved glycaemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. SGLT-2 inhibitors, including Farxiga (dapagliflozin), have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors reduce blood glucose as measured by HbA1c. \n \nAbout Qtern\nQtern combines two anti-hyperglycaemic agents with complementary mechanisms of action in a once-daily tablet: Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor; and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. The FDA approved Qtern based on data from a 24-week, Phase III, multi-centre, randomised, double-blind, placebo-controlled trial (n=315) designed to evaluate the efficacy and safety o...