Briefing Summary: US FDA Posts Advisory Committee Materials for Review of Merck’s Cardiovascular Outcomes Trial for Vytorin (IMPROVE-IT Trial) – DEC 14, 2015 (EMDAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, December 9, 2015 Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting. The Committee 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 Vytorin (ezetimibe/simvastatin) compared with simvastatin on the occurrence of cardiovascular (CV) events in patients with recent acute coronary syndrome. The results from this trial have been submitted to support supplemental new drug applications (sNDAs) 21445/S-038, for Zetia and 21687/S-054, Vytorin by MSD International GmbH (Merck). 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.

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