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Saxagliptin and dapagliflozin combo receives EMA positive opinion

The European Medicines Agency has received a positive opinion on AstraZeneca’s fixed-dose saxagliptin and dapagliflozin combination, Qtern®, from the Committee for Medicinal Products for Human Use. This means that marketing authorisation for the drug is highly likely.

If the authorisation goes ahead, the agent will be the first combination of a dipeptidyl peptidase-4 inhibitor and a sodium–glucose cotransporter 2 inhibitor to be approved.

The therapy is being recommended to improve glycaemic control in people with type 2 diabetes only when metformin and/or a sulphonylurea and one of the individual components do not provide adequate glycaemic control. It is also being recommended for people who are already being treated with the free combination of dapagliflozin and saxagliptin.

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