AstraZeneca announced Tuesday that the FDA approved Qtern (dapagliflozin/saxagliptin) for the treatment of type 2 diabetes. The company noted that the once-daily therapy is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes who have inadequate control with the SGLT-2 inhibitor Farxiga (dapagliflozin) or who are already treated with Farxiga and the DPP-4 inhibitor Onglyza (saxagliptin).
Elisabeth Björk, head of cardiovascular and metabolic diseases, global medicines development at AstraZeneca, said "the approval of Qtern is good news for patients who may benefit from improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet."
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According to AstraZeneca, the approval was based on results from a Phase III study designed to evaluate the efficacy and safety of Onglyza added to Farxiga in adults with type 2 diabetes who experienced inadequate glycaemic control with metformin. The combination therapy was previously rejected by the FDA, with the agency asking AstraZeneca to provide additional clinical data to support its submission.
In July last year, the European Commission approved Qtern as the first fixed-dose combination of a DPP-4 inhibitor and SGLT-2 inhibitor to be cleared in the region.
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