FDA Greenlights Diabetes Drug Combo

The FDA has approved AstraZeneca’s fixed-dose combination drug, Qtern (10 mg dapagliflozin and 5 mg saxagliptin), for the treatment of type 2 diabetes as an adjunct to diet and exercise. The drug is indicated to improve blood sugar levels in adults with type 2 diabetes who have been unable to achieve glycemic control with dapagliflozin or who are already treated with dapagliflozin and saxagiptin.

The treatment will provide an additional oral medicine option for patients who may benefit from improved blood sugar control with a DPP4 inhibitor and SGLT-2 inhibitor combo in a once-daily tablet.

SGLT-2 inhibitors, including dapagliflozin, reduce absorption of glucose from the blood and enable its removal via the urine. They have also demonstrated reductions in HbA1c and have been shown to result in weight loss and blood pressure reduction. DPP-4 inhibitors can reduce blood glucose as measured by HbA1c.

The drug is not meant to treat type 1 diabetes or diabetic ketoacidosis. Common adverse effects include upper respiratory tract infection, urinary tract infection, and dyslipidemia.

Reference

FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type 2 diabetes [news release]. Astrazeneca’s website. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2017/fda-approves-once-daily-qtern-dapagliflozin-and-saxagliptin-tablets-for-adults-with-type-2-diabetes-240217.html. Feb. 28, 2017.