FDA panel gives unanimous backing for Merck & Co's Vytorin for some kidney disease patients

4 November 2011

US drug giant Merck & Co (NYSE: MRK) said yesterday that the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration voted unanimously (16 to 0) to recommend approval of the firm’s blockbuster cholesterol lowerer Vytorin (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease. Merck’s shares edged nearly 1% higher to $34.19 on the news in November 2 New York trading.

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, the company noted. 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.

Final FDA decision expected 1st-qtr 2012

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