CV safety OK with saxagliptin.
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|
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