On December 14, 2015 the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will discuss the results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT). IMPROVE-IT was a clinical trial that studied the effect of ezetimibe/simvastatin compared with simvastatin on the occurrence of cardiovascular events in patients with recent acute coronary syndrome. The results from this trial have been submitted to support supplemental new drug applications 21445/S-038 and 21687/S-054, ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin) tablets, respectively, by MSD International GmbH. The proposed indication for ZETIA (in combination with a statin) and VYTORIN is to reduce the risk of cardiovascular events in patients with coronary heart disease.
See the FDA Announcement