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FDA Turns Down Expanded Use of Merck’s Vytorin and Zetia

Merck & Co., the second-biggest U.S. drugmaker, said cholesterol treatments Vytorin and Zetia failed to win approval to prevent heart attacks and strokes in patients with chronic kidney disease.

The Food and Drug Administration will allow the company to add study data to Vytorin’s label showing the treatment effectively lowers bad cholesterol in those patients, the Whitehouse Station, New Jersey-based company said in a statement today. Vytorin is a combination of Zetia and Zocor, or simvastatin, and has been available in generic form since 2006.

The agency rejected the expanded use because a study of the drugs didn’t examine the independent contributions of each medicine, Merck said. Advisers to the FDA recommended Nov. 2 that the agency approve Vytorin only for patients who aren’t undergoing dialysis.

The study results described in the new label “can help the medical community understand the role of lowering lipids with Vytorin in managing cardiovascular risk in patients with” chronic kidney disease, Michael Mendelsohn, Merck Research Laboratories senior vice president and head of atherosclerosis and cardiovascular research, said in the statement.

A clinical trial found that Vytorin reduced the risk of heart attack and stroke for patients with kidney disease by 16 percent compared with a placebo, FDA staff said in a preliminary review posted Oct. 28 on the agency’s website. Patients who aren’t on dialysis received the most benefit from the treatment, FDA staff wrote.

Lowering Bad Cholesterol

Merck reported in 2010 that its 9,000-patient study was the first to show that lowering so-called bad cholesterol, or LDL, cuts heart attack and stroke risks in people with chronic kidney disease. About 25 million people have chronic kidney disease in the U.S. and another 570,000 have end-stage renal disease, or kidney failure, according to the FDA.

Merck shares fell 10 cents, or less than one percent, to $38.68 at 4:15 p.m. in New York trading.

Zetia is expected to generate $2.44 billion in sales this year and Vytorin $1.8 billion, according to analyst estimates compiled by Bloomberg. Both are among Merck’s top 10 best-selling drugs.

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