SILVER SPRING, Md., Nov 2 (Reuters) - U.S. health advisers on Wednesday put some weight behind Merck & Co’s cholesterol-lowering drug Vytorin in preventing stroke and other heart problems in patients with chronic kidney disease.
The panel of outside experts convened by the Food and Drug Administration voted unanimously that the drug’s efficacy and safety gave enough weight to approve it for patients who are not yet on dialysis.
However, only six of 16 advisers voted in support of the drug in patients with end-stage renal disease who are already receiving dialysis, with the rest voting against the use of the drug in those patients.
Vytorin pairs a new type of cholesterol fighter Zetia, or ezetimibe, with Merck’s older statin drug Zocor, or simvastatin. It has been dogged by safety and effectiveness concerns for several years.