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GEN News Highlights : Jun 19, 2013

Disappointing Phase IV Cardiovascular Outcomes Results for AstraZeneca, BMS Type 2 Diabetes Drug

AstraZeneca and Britol-Myers Squibb (BMS) today report mixed top-line results for their Phase IV study evaluating cardiovascular outcomes in type 2 diabetes patients taking Onglyza® (saxagliptin).

While the SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) trial met the primary safety objective of non-inferiority for type 2 diabetes patients with either a history of established cardiovascular disease or multiple risk factors taking saxagliptin, it did not meet the primary efficacy objective—superiority, for a composite endpoint of cardiovascular death, non-fatal myocardial infarction, or non-fatal ischaemic stroke, when added to current standard of care, as compared to placebo.

Onglyza is central to an agreement between AstraZeneca and BMS to research, develop, and commercialize treatments for diabetes and related metabolic disorders. In a statement, the firms said they are continuing to analyze the SAVOR-TIMI-53 data, and planned to submit results to the European Society of Cardiology for potential presentation at its September gathering.