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FDA Grants Review Extension for New Diabetes Drug

 
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A review of the proposed diabetes drug saxagliptin has been extended from April 30 until July 30 by the U.S. Food and Drug Administration. The companies developing the drug, Bristol Myers Squibb and AstraZeneca, requested the extension.

Earlier this month, an FDA panel of outside medical experts determined that the drug doesn't carry an excess cardiovascular risk, the Wall Street Journal reported.

Saxagliptin is a type of drug called a DPP-4 inhibitor that's designed to increase levels of so-called incretin hormones in order to help lower blood glucose levels. The only DPP-4 drug currently on the market in the United States is Merck and Co.'s Januvia.

Late last year, the FDA said drug makers would have to conduct more stringent clinical trials for type 2 diabetes drugs in order to better assess the drugs' heart attack and stroke risks, the Journal reported.

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Anonymous

The only DPP-4 drug currently on the market in the United States is Merck and Co.'s Januvia.
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November 30, 2009 - 3:42am
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