The company has announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D).
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.
Across the trials, the combination of Forxiga, Onglyza and metformin was superior in reducing HbA1c versus Forxigacombined with metformin, Onglyza combined with metformin, or glimepiride combined with metformin. The combination of Forxiga, Onglyza and metformin with or without sulphonylurea (SU) was non-inferior to the combined use of insulin and metformin with or without SU in reducing HbA1c.
The safety results of the individual medicines in these trials were consistent with their known profile.
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.
Qtrilmetis approved in the US under the name Qternmet XR as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.