FDA EMDAC votes to recommend approval of Merck's VYTORIN for pre-dialysis CKD

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Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's VYTORIN® (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease. The Committee's vote was mixed (with the majority not in favor) regarding whether there is sufficient evidence to support approval specifically for patients with end-stage renal disease who are receiving dialysis. Merck is seeking indications for VYTORIN and for ZETIA® (ezetimibe) in combination with simvastatin to reduce the risk of major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP) trial. Neither product is currently indicated for this use.

The Committee's recommendation will be considered by the FDA in its assessment of these investigational uses for VYTORIN and ZETIA. The FDA is not bound by the Committee's guidance, but takes its advice into account. Merck plans to discuss the results of today's Advisory Committee meeting with the FDA in the near future. Currently, the Company's supplemental new drug applications remain under review, with agency action expected in the first quarter of 2012.

"We are pleased with the panel's recommendation and will continue working with the FDA on its evaluation of the proposed new indications for VYTORIN and ZETIA. If approved for these uses, these medicines have the potential to help to address a significant, unmet need among people with chronic kidney disease," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "The Advisory Committee vote brings VYTORIN and ZETIA one step closer to being an option for these patients who are at increased risk for cardiovascular events and procedures, such as heart attacks, strokes and certain types of heart surgery."

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