It intends to enhance glycaemic control when metformin and/or sulphonylurea and one of the mono-components of Qtern alone do not offer sufficientcontrol, or when a patient is already being treated with the free combination of saxagliptin and dapagliflozin.
The data supporting approval was generated from three trials in type 2 diabetes submitted to the European Medicines Agency.
In two trials, the combination of saxagliptin and dapagliflozin with metformin lead to statistically significant reductions in HbA1c, compared to patients treated with placebo.
An additional trial demonstrated that the combination added to metformin resulted in statistically superior reductions in HbA1c in compared to saxagliptin or dapagliflozin alone added to metformin.
In all the trials, the safety profile of Qtern was same to the known safety profiles of saxagliptin and dapagliflozin.
AstraZeneca vice president, head of cardiovascular and metabolic diseases for global Medicines Development said: “Nearly half of all people with type 2 diabetes are unable to reach their treatment goal and so risk developing complications due to hyperglycaemia.
“Qtern is the first combination product of its kind approved in Europe and an important new treatment option to help patients reach their goals through powerful HbA1c reduction.”
Image: Qtern is a fixed-dose combination of saxagliptin and dapagliflozin, two oral blood glucose lowering medicines. Photo: courtesy of AstraZeneca.