The US Food and Drug Administration has requested data from AstraZeneca as it investigates a possible association between use of the type 2 diabetes drug Onglyza and heart failure.
The agency will review Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin/metformin) after a study published in the New England Journal of Medicine reported an increased rate of hospitalisation for heart failure with use of the drugs. The FDA stressed that “at this time, we consider information from the NEJM study to be preliminary”, noting that the trial did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke.
AstraZeneca is expected to submit the trial data by early March and the FDA noted that the saxagliptin probe “is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.”. Onglyza, a DPP-4 inhibitor, was co-developed Bristol-Myers Squibb but AstraZeneca has just bought out the latter ‘s stake in the firms’ diabetes joint venture.
Meantime, AstraZeneca has returned the rights to “several pre-clinical compounds” to US firm Targacept. However, the firms’ collaboration, signed in 2005, “continues in full force and effect for remaining compounds”, Targacept said in a US Securities and Exchange Commission filing.
