AstraZeneca Receives FDA Approval for Type 2 Diabetes Tablet

FDA approves once-daily Qtern (dapagliflozin and saxagliptin) tablets for adults with type-2 diabetes.

AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.

Elisabeth Björk, vice president, head of cardiovascular and metabolic diseases, global medicines development at AstraZeneca, said: “Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the U.S. alone. The approval of Qtern is good news for patients who may benefit from improved glycemic 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 glycemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. SGLT-2 inhibitors, including Farxiga (dapagliflozin), 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.

Qtern combines two anti-hyperglycemic 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.

The FDA approved Qtern based on data from a 24-week, Phase III, multi-center, randomized, double-blind, placebo-controlled trial (n=315) designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in adult patients with type-2 diabetes who experienced inadequate glycemic control (HbA1c ≥7% to ≤10.5%) with metformin (≥1,500mg per day).

The safety of combined use of dapagliflozin and saxagliptin has been evaluated in a pooled safety analysis (N=1,169; 492 treated with Qtern) of three Phase III placebo-controlled clinical trials for up to 52 weeks.

(Source: AstraZeneca)