Merck , known as MSD outside the United States and Canada, issued the following statement after the conclusion of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to discuss the results of IMPROVE-IT, an investigational study comparing treatment with VYTORIN® (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes.
“Today’s discussion is one step in the regulatory process. We believe that IMPROVE-IT showed that ezetimibe in combination with a statin offers a significant benefit to high-risk patients with coronary heart disease (CHD) and are committed to continuing to work with the FDA so that they can complete the review of our request for new indications for VYTORIN and ZETIA® (ezetimibe). We believe that the results of the IMPROVE-IT trial address an important medical need in patients on statin therapy who are high-risk for cardiovascular events,” said Dr. Daniel Bloomfield, vice president, cardiovascular diseases, Merck Research Laboratories.
VYTORIN and ZETIA are currently indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia. The current U.S. Prescribing Information for both products states that the effect of ezetimibe on cardiovascular morbidity and mortality, alone or incremental to statin therapy, has not been determined. Merck has submitted the data from the IMPROVE-IT study to the U.S. Food and Drug Administration to support a new indication for reduction of cardiovascular events for ZETIA and VYTORIN.
The FDA considers the Committee’s recommendations when reviewing new indication applications but is not bound by the Committee’s guidance.
