AstraZeneca receives European approval for new diabetes therapy Qtern

AstraZeneca has announced that Qtern tablets have been approved by the European Commission for the treatment of type 2 diabetes. 

The tablets have been approved in all 28 EU member countries, as well as Iceland, Norway and Liechtenstein.

Qtern is designed for treating adults aged 18 upwards with type 2 diabetes. The tablet helps to improve glycaemic control when other medications fail to do so.

Elisabeth Bjork, head of cardiovascular and metabolic diseases within AstraZeneca's global medicines development unit, said: "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."

This fixed-dose combination of saxagliptin and dapagliflozin is indicated for adults with type 2 diabetes to improve glycaemic control when metformin and/or sulphonylurea and one of the mono-components of Qtern alone do not provide adequate control.

Approval was granted following three trials in type 2 diabetes that were submitted to the European Medicines Agency, which demonstrated the benefits Qtern offers compared to placebo and compared to dapagliflozin or saxagliptin alone.