AstraZeneca gains EU approval for combo diabetes drug Qtern

19 July 2016

AstraZeneca (LSE: AZN) today announced that the European Commission has approved its Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 European Union member countries plus Iceland, Liechtenstein and Norway.

The approval follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) at its May 2016 meeting. The fixed-dose combination of saxagliptin and dapagliflozin is the first DPP-4i/SGLT-2i combination product to be approved in Europe.

Last October, the Anglo-Swedish pharma major failed to win US approval for a new diabetes treatment that combines two of its existing drugs after the Food and Drug Administration issued a complete response letter calling for additional data that may require new clinical trials.

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