FDA panel backs Merck's Vytorin in predialysis CKD, but rejects dialysis use
This article was originally published in Scrip
Executive Summary
Merck could be the first company to market a drug in the US specifically indicated to reduce major cardiovascular events in patients with chronic kidney disease (CKD) if the US FDA takes the advice of its panel of outside expert advisers, which unanimously backed the expanded use of Vytorin (ezetimibe and simvastatin) at the 10/20mg dose as a treatment for that population not on dialysis.