January 25th, 2012

FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin

The FDA rejected a new indication for Merck’s Vytorin and Zetia (ezetimibe plus simvastatin and ezetimibe alone) in chronic kidney disease patients. As a consolation prize, however, the agency approved a new label for Vytorin that will incorporate the results of SHARP (Study of Heart and Renal Protection), which found that the drug combination reduced the incidence of major vascular events in patients with chronic kidney disease.

Merck said that the indication was not approved because the “independent contributions of ezetimibe and simvastatin were not assessed.” In a press release, Merck stated:

Because SHARP studied the combination of simvastatin and ezetimibe compared with placebo, it was not designed to assess the independent contributions of each drug to the observed effect; for this reason, the FDA did not approve a new indication for VYTORIN or for ZETIA® (ezetimibe) and the study’s efficacy results have not been incorporated into the label for ZETIA.

The FDA decision appears to run counter to the advice it received from its own advisory committee last November, which voted 16-0 in favor of an indication for Vytorin in predialysis patients. However, the committee also recommended against an indication for dialysis patients. The committee did not vote on an indication that would have included the entire SHARP population of predialysis and dialysis patients.


One Response to “FDA Rejects Proposed Chronic Kidney Disease Indication for Vytorin”

  1. This news item deserves attention. Many of us have argued that SHARP did not ask the most relevant question: whether ezetimibe adds to the risk reduction effect of statins. I understand that there is controversy about the efficacy of statins in patients on dialysis – but this study did not resolve that issue or test the incremental value of ezetimibe. The FDA was wise enough to recognize that limitation and decided against granting a new indication. Kudos to them for reading the study carefully.