Merck’s Bid For Vytorin CV Benefit Claim Muddied By Earlier Statin Failures In Dialysis Patients
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Vytorin/Zetia Affirmation Continues To Elude Merck With Denied CKD Indication
FDA shot down Merck’s bid to add an indication for cardiovascular risk reduction in renally impaired patients to Vytorin (ezetimibe/simvastatin) labeling, arguing the contribution of the two components to positive results wasn’t measured in the pivotal SHARP trial. Trial data can be added to the Vytorin label but not to labeling for Zetia (ezetimibe).
Merck's Vytorin/Zetia Headed For CV Outcomes Claim, But Will Dialysis Patients Be Off-Limits?
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.
FDA Cmte. To Weigh Breadth Of Vytorin/Zetia CV Risk Reduction Claim In Renally Impaired Patients
The Endocrinologic and Metabolic Drugs Advisory Committee will vote Nov. 2 on whether a new claim for reducing the risk of major cardiovascular events based upon the SHARP study should apply to both the pre-dialysis and dialysis populations.