Merck's Vytorin/Zetia Headed For CV Outcomes Claim, But Will Dialysis Patients Be Off-Limits?
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously endorses cardiovascular risk reduction claim for pre-dialysis chronic kidney disease patients, but votes 10-6 against extending the indication to the dialysis setting due to efficacy concerns.