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FDA extended time to review saxagliptin for treatment of diabetes
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The FDA has extended the date of the Prescription Drug User Fee Act from April 30, 2009 to July 30, 2009, stating that additional time is needed to complete the review of saxagliptin for the treatment of type 2 diabetes.
In April, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met to evaluate whether saxagliptin (Onglyza, Bristol-Myers Squibb) met recommendations from an FDA guidance released in December 2008, which recommended manufacturers developing new type 2 diabetes drugs provide evidence that the therapy will not increase risk for cardiovascular events.
The committee voted 10-2 that evidence of CV safety with saxagliptin was sufficient to rule out unacceptable, excess CV risk with the drug.
Although the majority of the committee voted that prospective review of findings from trials demonstrated CV event safety, all voted no in response to whether data were adequate to deem post-marketing CV trials unnecessary. The committee decided that further long-term, post-marketing studies including higher-risk patients were necessary.
Saxagliptin is an investigational, selective dipeptidyl peptidase-4 inhibitor. The application to the FDA includes use as a monotherapy, as an adjunct to diet and exercise, or in combination with antidiabetes medications.