FDA Approves Qtern for Adults With Type-2 Diabetes

Once-daily treatment combines SGLT-2 inhibitor and DPP-4 inhibitor

The FDA has approved once-daily Qtern (10 mg dapagliflozin and 5 mg saxagliptin, AstraZeneca) 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 (Farxiga, AstraZeneca) or who are already treated with dapagliflozin and saxagliptin (Onglyza, AstraZeneca).

Qtern combines two antihyperglycemic agents with complementary mechanisms of action in a once-daily tablet: dapagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, and saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.

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, including dapagliflozin, have demonstrated reductions in hemoglobin A1c (HbA1c) and have also reduced weight and blood pressure. DPP-4 inhibitors reduce blood glucose, as measured by HbA1c.

The FDA approved Qtern based on data from a 24-week, phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in 315 adults with type-2 diabetes who experienced inadequate glycemic control (HbA1c ranging from 7.0% to 10.5%) with metformin (1,500 mg/day or more). The safety of the combined use of dapagliflozin and saxagliptin was evaluated in a pooled safety analysis of three phase 3, placebo-controlled clinical trials, in which 492 patients were treated with Qtern for up to 52 weeks.

Source: AstraZeneca; February 28, 2017.