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news.AstraZeneca and Bristol-Myers Squibb have announced that the European Commission has granted marketing authorisation for Komboglyze (saxagliptin and metformin HCl immediate-release fixed dose combination) in 27 Member States of the European Union.
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Komboglyze combines saxagliptin (ONGLYZA), a DPP-4 inhibitor, and metformin immediate-release (metformin IR), a biguanide, in one tablet to treat Type 2 diabetes.
The indication for Komboglyze is as an adjunct to diet and exercise to improve glycaemic control in adult patients aged 18 years and older with Type 2 diabetes mellitus.
The marketing authorization is backed by saxagliptin development programme that involved 4,326 patients, including 2,158 individuals receiving saxagliptin plus metformin.
Bristol-Myers Squibb and AstraZeneca entered into a research collaboration in January 2007 for the development of select investigational drugs for type 2 diabetes.