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Onglyza makes it to FDA, but will it make it through?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb and AstraZeneca submitted their type 2 diabetes drug Onglyza (saxagliptin) to FDA on June 30 and to European regulators on July 1, the firms announce July 23. Approval would make it the second or third DPP-4 inhibitor on the U.S. market (Merck's Januvia was approved in 2006 and Takeda submitted alogliptin in late December 2007), but the timing may not be right for an easy diabetes approval. Due to concerns about cardiovascular safety with type 2 diabetes therapies, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted at its July 2 meeting to tighten cardiovascular review for such medications, and FDA is grappling with how to put that into practice

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