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The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.
On Sept. 23, 2019, AstraZeneca announced that Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablet, its combination diabetes medicine, has been recommended for marketing authorization in the European Union by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for treating adults with type-2 diabetes.
CHMP based its positive opinion on data from five Phase III trials that evaluated combinations of Forxiga (dapagliflozin) and Onglyza (saxagliptin) on a background of metformin in patients with inadequately controlled type-2 diabetes. Across the trials, the combination of Forxiga, Onglyza, and metformin was superior in reducing hemoglobin A1c (HbA1c) versus Forxiga combined with metformin, Onglyza combined with metformin, or glimepiride combined with metformin, AstraZeneca reported. 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.
CHMP recommended the marketing authorization for Qtrilmet to improve glycemic control when metformin with or without SU and either saxagliptin or dapagliflozin does not provide adequate glycaemic control, or when type 2 patients are already being treated with metformin, saxagliptin, and dapagliflozin.
Qtrilmet is approved in the United States under the name Qternmet XR as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.