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FDA backs Vytorin for kidney disease patients
Posted: Oct 31, 2011 10:41 AM by Matt Stafford
WASHINGTON (AP) - The Food and Drug Administration says Merck's cholesterol drug Vytorin helps reduce heart attack, stroke and related problems in patients with kidney disease, a potential new use for the blockbuster drug.
The agency's review also found no new safety concerns with Vytorin, which came under scrutiny for potential cancer risks in 2009.
Merck & Co. has asked the FDA to approve the drug for a new use in reducing heart-related problems chronic kidney disease patients. The combination pill is already cleared to reduce bad cholesterol.
FDA says that Vytorin lowered kidney disease patients' heart-related problems by 16 percent compared with placebo.
On Wednesday, a panel of non-government FDA advisers will vote on the new use.
Vytorin, a multibillion-dollar drug for Merck, combines two brand-name cholesterol pills Zocor and Zetia.
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