DEC 14 EMDAC RW

Results Wire: US FDA Advisory Committee Does Not Support Cardiovascular Events Claim for Merck’s Zetia (Ezetimibe) and Vytorin (Ezetimibe/Simvastatin) - DEC 14, 2015 (EMDAC)

On Monday, December 14, 2015, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) did not support, by a vote of 5-Yes to 10-No, with no abstentions, the approval of a labeling claim that would state that adding ezetimibe to statin therapy reduces the risk of cardiovascular events. The claim was proposed based on the results of the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), a clinical trial that studied the effect of Vytorin (ezetimibe/simvastatin) compared with simvastatin monotherapy on the occurrence of cardiovascular (CV) events in patients with recent acute coronary syndrome. The results from this trial were submitted to support supplemental new drug applications (sNDAs) 21445/S-038, for Zetia and 21687/S-054, Vytorin by MSD International GmbH (Merck).

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