WASHINGTON (AP) — 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 against the same 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.
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