Merck & Co.’s blockbuster cholesterol drug Vytorin won the backing of an advisory panel to prevent heart attack and stroke in some patients with kidney disease.
The panel voted 16-0 during a meeting today in Silver Spring, Maryland, that the Food and Drug Administration should approve Vytorin to treat patients with kidney disease who aren’t on dialysis. The advisers also decided 10-6 that the drug shouldn’t be allowed for patients with end-stage renal disease on dialysis treatment. The agency doesn’t have to follow the panel’s advice.
A clinical trial of the Whitehouse Station, New Jersey- based company’s drug showed it reduced the risk of “major vascular events” 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.
Merck reported last year 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 generated $2 billion in revenue last year from Vytorin, a combination of the cholesterol drugs Zetia and Zocor.
Zetia had 2010 sales of $2.3 billion, while Zocor earned $468 million. Zocor, or simvastatin, has been available in generic form since 2006.
Zetia works by limiting cholesterol absorption in the small intestine, while Zocor lowers cholesterol production by blocking an enzyme in the liver.
Merck gained less than 1 percent to $34.19 at the close in New York. The shares have declined 5.1 percent this year.
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