FDA delays review for three months of Bristol-Myers, Astra diabetes drug

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The FDA has extended the timeline to review Bristol-Myers Squibb and AstraZeneca's new drug application (NDA) for Onglyza for the treatment of type 2 diabetes.

The companies stated that the FDA has extended the Prescription Drug User Fee Act date from April 30 to July 30. The NDA for Onglyza (saxagliptin) was submitted to the FDA on June 30, 2008.

The London-based AstraZeneca and the New York City Bristol-Myers hoped their product, which earned backing from a regulatory advisory panel earlier in early April, would impact sales of the competing Januvia from the Whitehouse Station, N.J.-based Merck.

Onglyza, an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes, was specifically designed to be a selective inhibitor with extended binding to the DPP-4 enzyme, with dual routes of clearance. DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins.