Avapro renal disease supplement
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bristol-Myers Squibb and Sanofi-Synthelabo submit an sNDA for Avapro (irbesartan) Aug. 3 based on results of the PRIME study. The trial evaluated use of the angiotensin II receptor antagonist to prevent progression of renal disease in 2,300 patients with hypertension and type 2 diabetes. The sNDA is receiving priority review