ARTICLE | Company News

FDA panel to discuss IMPROVE-IT data

November 11, 2015 2:25 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on Dec. 14 to discuss sNDAs from Merck & Co. Inc. (NYSE:MRK) 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).

Last year, the study 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 at least 30 days after randomization at year seven vs. Merck's Zocor simvastatin (see BioCentury, Nov. 24, 2014). ...