FDA Panel Backs Expanded use of Merck's Vytorin
From Associated Press (November 2, 2011)
WASHINGTON -- Federal health experts are recommending that use of Merck's blockbuster cholesterol drug Vytorin be expanded to patients with kidney disease, but not those with late-stage disease who are on dialysis.
The Food and Drug Administration's panel of drug experts voted unanimously, 16-0, that data submitted by Merck show the drug is safe and effective for reducing heart attacks, strokes and other problems in kidney disease patients, according to an agency spokeswoman. The panel voted 10-6 that the data do not support use for patients on dialysis, the standard treatment for patients with failing kidneys who can no longer remove waste from their blood.
Vytorin, a $2 billion-a-year drug for Merck, combines two brand-name cholesterol drugs, Zocor and Zetia. Vytorin is already approved to reduce bad cholesterol, and Merck is seeking FDA approval for expanded use.
A Merck study of the drug showed a 22 percent decrease in cardiovascular events among pre-dialysis kidney disease patients. The reduction shrank to just 6 percent among patients on dialysis.
The FDA is not required to follow the guidance of its panels, though it often does.
Shares of Merck & Co. Inc. rose 14 cents to $34.20 in afternoon trading.
Posted: November 2011