FDA to review heart failure risk with AstraZeneca diabetes drug

The US Food and Drug Administration has requested clinical trial data from Anglo-Swedish drug major AstraZeneca (LSE: AZN), the manufacturer of saxagliptin, to investigate a possible association between use of the type 2 diabetes drug and heart failure.

The FDA request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment (placebo).

The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. However, there was a significant excess in hospitalization for heart fail in the saxagliptin group (3.5% versus 2.8%, p=0.007). The manufacturer is expected to submit the trial data to FDA by early March 2014, after which the FDA says it will conduct a thorough analysis and report its findings publicly.