The European Commission has green-lighted Qtern (saxagliptin/dapagliflozin) for the treatment of type II diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway.
The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe, and offers a dual approach to lowering blood glucose levels.
The treatment is targeted towards adults with type II diabetes to improve glycaemic control when metformin and/or sulphonylurea and one Qtern's components alone do not provide adequate control, or when a patient is already being treated with the free combination of saxagliptin and dapagliflozin.
"Nearly half of all people with type II 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," said Elisabeth Björk, head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AZ.
In clinical trials, Qtern with metformin resulted in statistically significant reductions in HbA1c in comparison to patients treated with placebo, and compared to saxagliptin or dapagliflozin alone added to metformin.
Around 700 people a day are diagnosed with diabetes, which equates to one person every two minutes, and it is estimated that, by 2025, five million people will have the condition, according to Diabetes UK.