February 28, 2017
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FDA approves combination dapagliflozin/saxagliptin tablets for type 2 diabetes

The FDA has approved a once-daily combination of the SGLT2 inhibitor dapagliflozin and the DPP-IV inhibitor saxagliptin for the treatment of type 2 diabetes, AstraZeneca announced in a press release.

The combination therapy (Qtern), is intended for patients with type 2 diabetes inadequately controlled with dapagliflozin (Farxiga; 10 mg) or who are already treated with both dapagliflozin and saxagliptin (Onglyza) therapy. The drug is indicated as an adjunct to diet and exercise.

“Type2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the U.S. alone,” Elisabeth Björk, vice president, head of cardiovascular and metabolic diseases, global medicines development at AstraZeneca, said in the release. “The approval of Qtern is good news for patients who may benefit from improved glycemic control by adding a DPP-IV inhibitor to a SGLT2 inhibitor in a convenient, once-daily tablet."

SGLT-2 inhibitors help patients achieve improved glycemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. SGLT-2 inhibitors have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-IV inhibitors reduce blood glucose as measured by HbA1c.