Komboglyze saxagliptin/metformin regulatory update

FDA is investigating a "possible association" between the use of saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor from AstraZeneca, and heart failure. The agency requested the pharma submit full data by early March from the Phase IV SAVOR-TIMI-53 cardiovascular outcomes trials and additional analyses of the trial. Data from the trial - which evaluated once-daily Onglyza saxagliptin in about 16,500 Type II diabetics - were published in September in the New England Journal of Medicine. In the trial, more patients in the Onglyza arm were hospitalized for heart failure compared to placebo (3.5% vs. 2.8%, HR=1.27, 95% CI: 1.07, 1.51, p=0.007). FDA noted that there was not an increased rate of death or other major CV risks for patients receiving saxagliptin. The agency will conduct independent analyses of the datasets and study report and expects to come to a decision about 6 months after submission of the data. AZ said it plans to submit the data by early March (see BioCentury, Sept. 9, 2013).

SAVOR-TIMI-53 was designed to fulfill a postmarketing requirement requested by FDA. In September, AZ and former partner Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) had said that they planned to share the full data with regulatory authorities. ...