Vytorin ezetimibe/simvastatin regulatory update

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet on Dec. 14 to discuss sNDAs from Merck to include reductions in cardiovascular events on the labels of cholesterol drugs Vytorin ezetimibe/simvastatin and Zetia ezetimibe. The sNDAs are based on data from the Phase III IMPROVE-IT trial of Vytorin in high-risk patients presenting with acute coronary syndrome (ACS).

Data from IMPROVE-IT showed Vytorin met the primary composite endpoint of reducing the proportion of patients experiencing CV death, non-fatal myocardial infarction (MI), non-fatal stroke, re-hospitalization for unstable angina or coronary revascularization occurring <=30 days after randomization at year 7 vs. Merck’s Zocor simvastatin (see BioCentury, Nov. 24, 2014 & March 23, 2015). ...