FDA declines expanded approval for cholesterol drugs.

Bloomberg News (1/26, Edney) reports, "Merck & Co., the second-biggest US drugmaker, said cholesterol treatments Vytorin [ezetimibe/simvastatin] and Zetia [ezetimibe] failed to win" Food and Drug Administration "approval to prevent heart attacks and strokes in patients with chronic kidney disease." The agency "will allow the company to add study data to Vytorin's label showing the treatment effectively lowers bad cholesterol in those patients," the company said in a statement. Merck said, "The agency rejected the expanded use because a study of the drugs didn't examine the independent contributions of each medicine." Also covering the story is Reuters (1/26, Yukhananov).

        FDA approves new label for ezetimibe-simvastatin. MedPage Today (1/26, Kaiser) reports, "The FDA has approved new labeling for the single-tablet combination of ezetimibe-simvastatin (Vytorin), a cholesterol-lowering drug, for use in patients with moderate to severe chronic kidney disease (CKD)." The agency "however, only updated the label and did not approve a new indication for the drug because the SHARP study examining its efficacy was not designed to assess the independent contributions of ezetimibe (Zetia) and simvastatin (Zocor) to the observed effect," Merck said in a statement. "The FDA's Endocrinologic and Metabolic Drugs Advisory Committee also voted 10-6 against recommending approval for use of the drug in end-stage renal disease (ESRD) patients on dialysis." Also covering the story is Reuters (1/26).