AstraZeneca gets EU authorisation for 'Qtrilmet' diabetes treatment

AstraZeneca announced on Monday 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.

The FTSE 100 pharmaceuticals giant 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 3 trials, which evaluated combinations of ‘Forxiga’ - dapagliflozin - and ‘Onglyza’ - saxagliptin - on a background of metformin, in patients with inadequately-controlled type-2 diabetes.

It said the primary endpoint in those trials was mean change from baseline in HbA1c - average blood glucose levels - at week 24 or 52.

Across the trials, AstraZeneca reported that the combination of Forxiga, Onglyza and metformin was superior in reducing HbA1c compared to Forxiga combined with metformin, Onglyza combined with metformin, or glimepiride combined with metformin.

The combination of Forxiga, Onglyza and metformin with or without sulphonylurea was non-inferior to the combined use of insulin and metformin with or without sulphonylurea in reducing HbA1c, the company added.

It said the safety results of the individual medicines in the trials were consistent with their known profile.

“The CHMP recommended the marketing authorisation for Qtrilmet to improve glycaemic control when metformin with or without sulphonylurea and either saxagliptin or dapagliflozin does not provide adequate glycaemic control, or when type-2 diabetes patients are already being treated with metformin, saxagliptin and dapagliflozin,” the AstraZeneca board said in its statement.

“Qtrilmet is approved in the United States under the name Qternmet XR as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes.”