FDA Approves New Option for Type 2 Diabetes

The FDA has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of patients with type 2 diabetes, as an adjunct to diet and exercise for the improvement of glycemic control.  Specifically, the drug is meant to treat individuals who have inadequate control with dapagliflozin (10mg) or who are already being treated with dapagliflozin and saxagliptin.

Qtern was approved based on data from a 24-week, Phase II, multi-center, randomized, double-blind, placebo-controlled trial with 315 participants. The safety of combined dapagliflozin and saxagliptin use was also evaluated in a pooled safety analysis of 1169 participants, 492 of whom were treated with Qtern, of 3 Phase III placebo-controlled clinical trials.
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Contraindications include prior serious hypersensitivity reaction to Qtern or its components, or moderate to severe renal impairment, end-stage renal disease, or dialysis.

The most common adverse reactions include upper respiratory tract infection, urinary tract infection, and dyslipidemia.

—Michael Potts

Reference:

FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes [press release]. AstraZeneca. February 28, 2017. 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.