Vytorin is already approved for lowering cholesterol, but the company had been hoping to expand its use to prevent stroke and other heart problems in patients with chronic kidney disease.
It was the first randomized controlled study that showed statins can lower the rate of heart problems in kidney disease patients, Merck said.
However, because the study did not look at the individual contributions of Zetia and Zocor to the reduction in heart pFDA label shows Merck cholesterol drug helps heart_ heart disease symptomsroblems, the FDA did not approve a new indication for Vytorin or Zetia, Merck said.
(Reuters) - U.S. health regulators amended the prescribing label for Merck & Cos cholesterol-lowering drug Vytorin to show it prevents heart problems in patients with chronic kidney disease, but stopped short of approving its use for that purpose.
The new labeling reflects the findings of the SHARP study, which showed Vytorin reduced the risk of major vascular problems in patients with moderate to severe chronic kidney disease.
FDA label shows Merck cholesterol drug helps heart_ heart disease symptoms,The decision means Merck cannot market Vytorin as a treatment for reducing the rate of heart problems in kidney patients, though it can discuss the new label with doctors.
Merck had asked the Food and Drug Administration to approve the new indication, and the company relayed the agencys decision on Wednesday.
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Vytorin pairs a new type of cholesterol fighter Zetia, or ezetimibe, with Mercks older statin drug Zocor, or simvastatin.
Mercks patents on both Vytorin and Zetia expire in 2017. In 2010, Vytorin posted sales of $2 billion and Zetia reaped $2.3 billion.
(Additionheart disease symptomsal reporting by Esha Dey in Bangalore; Editing byDerek Caney)
By Anna Yukhananov
Merck shares slipped 0.5 percent to $38.57 in morning trading on the New York Stock Exchange, slightly above a 0.7 percent dip in the Arca Pharmaceuticals Index.
The final outcome is slightly disappointing, as many street observers had expected an actual new indication claim, Mark Schoenebaum, an analyst at ISI Group, said in a report.
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Chronic kidney disease affects about 14 percent of the U.S. population and puts people at a high risk of developing heart disease and having a stroke or heart attack.
