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CV safety OK with saxagliptin.

Cardiovascular safety data for the investigational diabetes drug saxagliptin are sufficient to rule out unacceptable excess risk in the population studied, but the manufacturer should conduct longer postmarketing studies in patients at higher risk for cardiovascular events, a federal advisory panel concluded.

Bristol-Myers Squibb's saxagliptin (Onglyza), a once-daily oral treatment, is the first oral antidiabetic agent to be reviewed by an FDA advisory panel since December 2008, when the agency began requiring manufacturers of type 2 diabetes drugs to conduct more thorough evaluations of cardiovascular safety (www.fda.gov/cder/guidance/8576fnl.pdf).

Bristol-Myers Squibb and its development partner, AstraZeneca, are seeking approval for saxagliptin as monotherapy (as an adjunct to diet and exercise); as an add-on to metformin, a thiazolidine-dione, or a sulfonylurea; or as initial therapy with metformin, in a usual daily dosage of 5 mg, or 2.5 mg per day for patients with renal impairment.

The advisory panel concurred by a 10-2 vote that the data did support cardiovascular efficacy for the relatively low-risk population studied. The vote to require BMS to conduct further study in high-risk populations was unanimous at 12-0.
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Title Annotation:NEWS FROM THE FDA
Publication:Internal Medicine News
Date:May 1, 2009
Words:186
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