FDA backs Vytorin for kidney disease patients
Posted: Wednesday, November 2, 2011 8:02 pm
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 2008.
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.
Published in The Messenger 11.2.11