Once-daily diabetes drug approved
FDA approved 10 mg dapagliflozin and 5 mg saxagliptin (Qtern, ), to treat type 2 diabetes.
The once-daily therapy is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with dapagliflozin (10 mg) or who are already treated with dapagliflozin and saxagliptin.
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“Type 2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone,” said Elisabeth Björk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca, in a company statement. “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.”
SGLT-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 dapagliflozin (Farxiga) 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.
FDA approved Qtern based on data from a 24-week, phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in adult patients with type 2 diabetes who experienced inadequate glycemic control with metformin.
The safety of combined use of dapagliflozin and saxagliptin has been evaluated in a pooled safety analysis of three phase 3 placebo-controlled clinical trials for up to 52 weeks.
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