FDA panel to discuss CV benefit of Vytorin, Zetia

FDA reviewers questioned whether adding Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK) to statin therapy can reduce cardiovascular events in a broad patient population compared to a statin alone, or whether such a claim should be confined to subpopulations.

The reviewers raised the questions in briefing documents released ahead of Monday's meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss sNDAs proposing to add language to labels of Merck's Vytorin ezetimibe/simvastatin and Zetia stating that the drugs reduce the risk of cardiovascular events in patients with coronary heart disease, based on data from Merck's Phase III IMPROVE-IT trial. ...