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Onglyza advisory panel review

Executive Summary

Bristol-Myers Squibb/AstraZeneca's DPP-4 inhibitor Onglyza (saxagliptin) will be reviewed by FDA's Endocrinologic and Metabolic Drugs Advisory Committee April 1. The application was filed last summer and an action date is set for April 30 (1"The Pink Sheet" DAILY, July 23, 2008). Novo Nordisk's GLP-1 analog Victoza (liraglutide) already was on the committee calendar for April 2, an event that has been anticipated as the showcase for real-world implementation of new cardiovascular safety guidance governing type 2 diabetes drugs. Unveiled in December, that guidance requires an in-depth safety review for type 2 diabetes medications, including studies of CV mortality, myocardial infarction and stroke (2"The Pink Sheet" DAILY, Dec. 17, 2008)

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