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FDA Backs Vytorin For Kidney Disease Patients

By: AP
Posted: Mon 11:06 AM, Oct 31, 2011

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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