FDA fails to approve cholesterol drug for kidney disease

U.S. health regulators amended the prescribing label for Merck & Co’s 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 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 agency’s decision on Wednesday.

“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.

Vytorin pairs a new type of cholesterol fighter Zetia, or ezetimibe, with Merck’s older statin drug Zocor, or simvastatin.

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.

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.

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.

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 problems, the FDA did not approve a new indication for Vytorin or Zetia, Merck said.

Merck’s patents on both Vytorin and Zetia expire in 2017. In 2010, Vytorin posted sales of $2 billion and Zetia reaped $2.3 billion.

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By Anna Yukhananov