Bristol-Myers (BMY), AstraZeneca (AZN) SAVOR-TIMI-53 Misses Primary Efficacy Endpoint in Phase 4

June 19, 2013 6:20 AM EDT Send to a Friend
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Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced top line results of the Phase 4 SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin). In this study of adult patients with type 2 diabetes with either a history of established cardiovascular disease or multiple risk factors, Onglyza met the primary safety objective of non-inferiority, and did not meet the primary efficacy objective of superiority, for a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischaemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo.

These preliminary SAVOR-TIMI-53 data are being analyzed and the study results will be submitted to the European Society of Cardiology (ESC) for potential presentation at the ESC Congress in September.


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