Tuesday, February 11, 2014

FDA gets on Onglyza's case

The Food and Drug Administration has requested clinical trial data from AstraZeneca on saxagliptin, which is marketed on its own as Onglyza or in combination with an oral hyperglycemic drug as Kombilgyze XR, for type-2 diabetes.

The FDA request resulted from a large study called the SAVOR trial published in the New England Journal of Medicine last September. The study reported an increased rate of hospitalization for heart failure with use of saxagliptin, compared with a placebo group. The figures were 3.5% for the saxagliptin group compared with 2.8% in the placebo group, in a total of 16,492 patients.

Read more: http://www.nasdaq.com/article/fda-to-review-data-for-astrazeneca-diabetes-drug-20140211-01073#ixzz2t2ytcYKx

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