AstraZeneca, Bristol-Myers Squibb obtain FDA approval for Onglyza

The FDA approved AstraZeneca and Bristol-Myers Squibb's Onglyza (saxagliptin), a once-daily tablet to treat type 2 diabetes in adults. Onglyza is part of the DPP-4 inhibitor class of diabetes drugs, which includes Merck & Co.'s Januvia (sitagliptin).

The FDA noted that while Onglyza was not associated with an increased risk for cardiovascular events in patients who were at low risk for such events, it is requiring the drugmakers to conduct post-market testing in order to "specifically evaluate cardiovascular safety in a higher risk population."

In April, a majority of FDA advisory panel members voted that study data for the compound provided sufficient evidence to rule out "unacceptable excess cardiovascular risk relative to competitors." However, panellists also recommended that a post-marketing trial be performed to assess Onglyza's potential cardiovascular risks.

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