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Vanlev in refractory patients

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Bristol-Myers Squibb could seek approval of Vanlev (omapatrilat) through a study demonstrating a benefit in patients who have persistent serious hypertension after treatment with drugs from three different antihypertensive classes, FDA's Cardiovascular & Renal Drugs Advisory Committee suggests at its July 19 meeting. The committee voted five to one against approval because of concerns that benefits shown over enalapril (a 3.2 mm Hg greater reduction in systolic blood pressure and a 1.9 mm Hg greater reduction in diastolic BP in the OCTAVE trial) do not outweigh the risk of angioedema (2.17% for omapatrilat vs. 0.68% for enalapril

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