The approval is backed by Phase 3b 24-week data that demonstrated the efficacy of Onglyza in reducing blood sugar levels in type 2 diabetes as compared to placebo.
AstraZeneca chief medical officer Howard Hutchinson said the move by the European agency would help in the development of type 2 diabetes treatment.
Bristol-Myers Squibb and AstraZeneca entered into a research collaboration in January 2007 for the development of select investigational drugs for type 2 diabetes.
Onglyza is a trademark of the Bristol-Myers Squibb Company.