AstraZeneca wins approval for adult type-2 diabetes treatment

AstraZeneca has been given a green light by US drug regulators for its once-daily treatment of type-2 diabetes, called Qtern.

The medicine, a combination of two anti-hyperglycaemic agents, is given to help improve blood sugar level control in adults with type-2 diabetes who are not gaining enough stability by taking dapagliflozin alone or who are already treated with dapagliflozin and saxagliptin.

The US Food and Drug Administration approved Qtern based on data from a 24-week, Phase III, multi-centre, randomised, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of saxagliptin added to dapagliflozin in adult patients.

AstraZeneca's head of cardiovascular and metabolic diseases, Elisabeth Björk, said: "Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone.

"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."