FDA Staff Say Merck Drug Helps Kidney Patients

Drugs reviewers said Merck's cholesterol-lowering drug Vytorin was effective in reducing the rate of heart attacks or other cardiovascular problems in patients with kidney disease.

Reviewers from the U.S. Food and Drug Administration also said it is unlikely the blockbuster drug causes or promotes cancer. The documents were released online.

The FDA review could help allay fears about the popular drug after a 2008 clinical trial showed substantially more cancer cases among patients taking Vytorin—which pairs a new type of cholesterol fighter Zetia with Merck's older statin drug Zocor—than those taking a placebo.

The trial hit sales of the drug, although it still posted sales of $2 billion in 2010. Zetia, or ezetimibe, had sales last year of $2.3 billion.

Merck is seeking to expand Vytorin's indication to treating heart problems in chronic kidney patients. It is currently approved to help lower cholesterol.

Chronic kidney disease, which affects about 14 percent of the U.S. population, raises the risk of developing heart disease or having a stroke.

An FDA panel of outside experts will discuss the drug on Wednesday, after which the FDA will make the final decision.