FDA Cmte. To Weigh Breadth Of Vytorin/Zetia CV Risk Reduction Claim In Renally Impaired Patients
This article was originally published in The Pink Sheet Daily
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.
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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).