Qtern, a fixed-dose of Saxagliptin and Dapagliflozin, for adults with type 2 diabetes mellitus: positive opinion from CHMP
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has issued a positive opinion, recommending the approval of Qtern ( Saxagliptin and Dapagliflozin ) tablets for the treatment of adults with type-2 diabetes.
The fixed-dose combination of Saxagliptin and Dapagliflozin has the potential to be the first DPP-4i/SGLT-2i combination product approved in Europe.
Qtern is a fixed-dose combination of Saxagliptin and Dapagliflozin being developed as a treatment for patients with type 2 diabetes mellitus in adults aged 18 years and older.
It is recommended to be indicated as a treatment to improve glycaemic control when metformin and/or sulphonylurea and one of the mono-components of Saxagliptin and Dapagliflozin alone do not provide adequate glycaemic control, or when a patient is already being treated with the free combination of Saxagliptin and Dapagliflozin.
The submission included data from three studies in type 2 diabetes mellitus. In two studies, the combination of Dapagliflozin and Saxagliptin with Metformin resulted in statistically significant reductions in glycated haemoglobin ( HbA1c ) in comparison to patients treated with placebo that required additional control to existing Saxagliptin and Metformin or Dapagliflozin and Metformin therapy.
An additional study showed that the combination of Dapagliflozin and Saxagliptin added on to Metformin resulted in statistically superior reductions in HbA1c in comparison to patients treated with Dapagliflozin or Saxagliptin alone added to Metformin.
In these trials, the safety profile of Qtern was similar to the known safety profiles of Saxagliptin and Dapagliflozin. ( Xagena )
Source: AstraZeneca, 2016