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Avapro and Cozaar for diabetic nephropathy

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb/Sanofi-Synthelabo's Avapro (irbesartan) and Merck's Cozaar (losartan) share Sept. 17 supplemental approvals for treatment of diabetic nephropathy with elevated serum creatinine and proteinuria in patients with type 2 diabetes and hypertension. Avapro's supplemental approval was based on the IDNT trial, which FDA's Cardiovascular & Renal Drugs Advisory Committee felt did not provide sufficient evidence due to its "modest" p-value. Merck's Cozaar supplement was based on the RENAAL study, which the committee also did not feel was sufficient, as it failed to reach statistical significance. However, the advisory committee was in favor of approval when viewing the data from the two trials in conjunction. The firms reached an agreement to reference each other's studies in the sNDAs. Labeling refers only to their own studie

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