EMA committee recommends marketing approval for AstraZeneca's Qtrilmet to treat type-2 diabetes
AstraZeneca, a global, science-led biopharmaceutical company, 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 Forxiga combined 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.