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Astrazeneca wins FDA approval for triple therapy for type 2 diabetes

Astrazeneca said Wednesday that the U.S. Food and Drug Administration approved its Qternmet XR sustained-release tablet for use in combination with diet and exercise to improve blood sugar levels in adults with type 2 diabetes. Qternmet XR is an oral triple therapy consisting of dapagliflozin, saxagliptin, and metformin.
Type 2 diabetes is the most common form of the disease, in which people develop resistance to insulin and their blood sugar levels rise. People with diabetes have a two-to threefold increased risk of heart disease and stroke. Diabetes is also the leading cause of kidney failure. According to the International Diabetes Federation (IDF), there were about 425 million adults with diabetes in 2017, and that number is expected to grow to 629 million by 2045.
Qternmet XR is a once-daily combination pill made up of three already approved drugs. Dapagliflozin, a specific sodia-glucose cotransporter 2 (SGLT-2) inhibitor, pumps more glucose out of the urine by inhibiting its reabsorption by the kidneys. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that reduces blood sugar levels by inhibiting the secretion of glucagon by stimulating the secretion of incretin. Metformin has long been the drug of choice for type 2 diabetes.
This approval was based on the results of two phase 3 trials that evaluated the combination of dapagliflozin and saxagliptin in the context of background metformin therapy. In both trials, the combination of 5 mg dapagliflozin /5 mg saxagliptin or 10 mg dapagliflozin /5 mg saxagliptin resulted in statistically significant reductions in patients' glycosylated hemoglobin (HbA1c) levels and increased the number of patients achieving the target level of HbA1c treatment.
We hope that this new drug will be on the market soon and bring more convenient treatment options to people with type 2 diabetes.
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