FDA AdComm to Review Merck’s Trial Data for Coronary Heart Disease Drugs

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review data from Merck’s IMPROVE–IT trial Dec. 14.

The trial results — which studied the effect of ezetimibe and simvastatin compared with simvastatin on the occurrence of cardiovascular events in patients with recent acute coronary syndrome — have been submitted to support the sNDAs for Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) tablets.

The advisory committee will review whether labeling for the cholesterol-lowering agents should be updated to include reductions in cardiovascular events in patients with coronary heart disease.