AstraZeneca garners FDA approval of Qternmet XR for adults with type 2 diabetes

AstraZeneca announced Friday that the FDA approved Qternmet XR (dapagliflozin/saxagliptin/metformin) as an oral adjunct treatment to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The once-daily medicine combines the SGLT-2 inhibitor Farxiga (dapagliflozin), the DPP‑4 inhibitor Onglyza (saxagliptin) and metformin hydrochloride extended release. 

According to the company, approval of Qternmet XR was supported by data from two Phase III studies in which patients with inadequately controlled type 2 diabetes received combinations of Farxiga and Onglyza on a background of metformin over 24 weeks. Results from both trials showed that the triple therapy was associated with significant decreases in HbA1c and an increase in the number of patients achieving the recommended HbA1c treatment goal of less than 7 percent.

The combination of Farxiga and Onglyza was approved by the FDA in 2017 for the treatment of type 2 diabetes under the name Qtern. Last month, AstraZeneca reported that first-quarter sales of Farxiga climbed 17 percent year-over-year to $349 million.

To read more Top Story articles, click here.