AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Monday the recommendation for marketing authorisation in the EU for Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets for the treatment of adults with type-2 diabetes (T2D).

The company said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on data from five phase III trials, which evaluated combinations of Forxiga(dapagliflozin) and Onglyza (saxagliptin) on a background of metformin in patients with inadequately-controlled T2D. The primary endpoint in these trials was mean change from baseline in HbA1c (average blood glucose levels) at week 24 or 52.

AstraZeneca added that the CHMP recommended the marketing authorisation for Qtrilmet to improve glycaemic control when metformin with or without SU and either saxagliptin or dapagliflozin does not provide adequate glycaemic control, or when T2D patients are already being treated with metformin, saxagliptin and dapagliflozin.

Currently, Qtrilmetis is approved in the US under the name Qternmet XR as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal and Metabolism (CVRM) and Respiratory.