FDA green lights AstraZeneca type-2 diabetes drug
AstraZeneca has announced that its type-2 diabetes treatment Qtern (10mg dapagliflozin and 5mg saxagliptin) has received the approval of the US Food and Drug Administration.
The drug has been indicated as a supplement to diet and exercise to improve glycaemic control in adults with type-2 diabetes who have shown inadequate response with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.
Qtern is a once-daily tablet comprising dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor which functions by reducing the reabsorption of glucose from the blood and facilitating its removal via the urine, leading to improved glycaemic control. The other ingredient, saxagliptin, is a DPP-4 inhibitor which helps to reduce blood glucose as measured by HbA1c.
“Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone,” explained Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca. “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.”