FDA Requests Clinical Data from AstraZeneca due to Heart Failure Risk Associated with Type 2 Diabetes Drugs Onglyza® and Kombiglyze XR®
The United States Food and Drug Administration (FDA) has issued a Drug Safety Communication informing doctors and consumers that it has “requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.”
Saxagliptin is a Type 2 diabetes drug marketed as Onglyza® and Kombiglyze XR® – both of which are marketed by Astra Zeneca (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, BristolMyers-Squibb, according to Forbes). Onglyza® was approved by the FDA in July 2009, while Kombiglyze XR® was approved by the FDA in November 2010.
The FDA’s request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization due to heart failure with use of saxagliptin compared to inactive treatment. However, the study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The FDA considers this study to be “preliminary”, so it has requested the trial data to be directly submitted by the manufacturer for FDA’s review. The manufacturer is expected to submit the trial data requested by FDA in early March 2014 so that FDA can conduct a thorough analysis and report its findings publicly.
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