US FDA mixed views on Vytorin and Zetia

US drug giant Merck & Co (NYSE: MRK) yesterday received Food and Drug Administration approval to update the label for Vytorin (ezetimibe/simvastatin) to include results from the SHARP (Study of Heart and Renal Protection) study showing that the drug effectively lowered low density lipoprotein (LDL) cholesterol in chronic kidney disease (CKD) patients with few major vascular events compared to placebo.

However, the FDA denied the approval for the expanded use of Vytorin and Zetia (ezetimibe) for the prevention of heart attacks and strokes in patients with CKD, saying that independent contributions of the medicines were not assessed. Merck’s shares fell less than1% to $38.6 by close of New York trading yesterday.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee last fall voted unanimously (16 to 0) to recommend approval of the cholesterol lowerer Vytorin for use in patients with pre-dialysis chronic kidney disease (The Pharma Letter November 4, 2011).