Qternmet XR is a combination product that contains dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin, a biguanide. Initiation with Qternmet XR is intended only for patients currently taking metformin.
The approval was based on data from two phase 3 trials which evaluated combinations of dapagliflozin and saxagliptin on a background of metformin over 24 weeks, in patients with inadequately-controlled T2DM.
In one study, concomitant addition of dapagliflozin 5mg and saxagliptin 5mg + metformin resulted in statistically significant decreases in HbA1c (-1.02), compared with dapagliflozin + metformin (-0.62) or saxagliptin + metformin (-0.69). In addition, a larger proportion of patients in the dapagliflozin and saxagliptin + metformin group achieved the therapeutic glycemic goal of HbA1c <7% vs those in the dapagliflozin + metformin and saxagliptin + metformin groups (42.8% vs 21.8% and 28.5%, respectively).
A second study showed that the concomitant addition of dapagliflozin 10mg and saxagliptin 5mg + metformin resulted in statistically significant decreases in HbA1c (-1.49) compared with dapagliflozin + metformin (-1.23) or saxagliptin + metformin (-1.00). The percentage of patients who achieved HbA1c <7% was 40.2% for dapagliflozin and saxagliptin + metformin, 21.2% for dapagliflozin + metformin, and 16.5% for saxagliptin + metformin.
Qternmet XR will be supplied in 4 tablets strengths: dapagliflozin 2.5mg/saxagliptin 2.5mg/metformin HCl 1000mg; 5mg/2.5mg/1000mg; 5mg/5mg/1000mg; and 10mg/5mg/1000mg.
In addition to the Qternmet XR approval, the FDA has also updated the indication for Qtern (dapagliflozin and saxagliptin) as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Previously, the indication stated that the treatment was for patients who were inadequately controlled with dapagliflozin or who were already being treated with dapagliflozin and saxagliptin.
The Dosing and Administration section of the labeling has also been updated to include dosing information for patients who have previously not received dapagliflozin. For these patients, the recommended starting dose is dapagliflozin 5mg/saxagliptin 5mg, which corresponds to a new tablet strength of Qtern.
For more information visit qtern-hcp.com.