Onglyza not superior to placebo on CV efficacy endpoint

Bristol-Myers Squibb Co. (NYSE:BMY) and partner AstraZeneca plc (LSE:AZN; NYSE:AZN) said once-daily Onglyza saxagliptin missed the primary efficacy endpoint in the Phase IV SAVOR-TIMI-53 cardiovascular outcomes trial in 16,500 Type II diabetics who had either a history of established cardiovascular disease or multiple risk factors. Specifically, Onglyza was not superior to placebo in reducing a composite of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal ischemic stroke. Onglyza did meet the primary safety endpoint of non-inferiority to placebo.

Bristol-Myers said the trial was designed to fulfill a postmarketing requirement requested by FDA for the oral dipeptidyl peptidase-4 (DPP-4) inhibitor. The pharma said the partners plan to share the full data with regulatory authorities, but declined to disclose details. AstraZeneca could not be reached for comment. ...