FDA Advisory Committee Recommends Approval for Vytorin in Pre-Dialysis CKD Patients

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee strongly supported the combination of ezetimibe and simvastatin (Vytorin, Merck) to prevent cardiovascular events in pre-dialysis chronic kidney disease (CKD) patients. But the panel voted against recommending the use of Vytorin in patients with end-stage renal disease on dialysis. The votes were 16-0 in favor of the pre-dialysis indication and 10-6 against the dialysis indication.

The votes were based on the FDA review of the SHARP trial, which found a highly significant 16% reduction in the rate of major vascular events compared with placebo. However, the beneficial effect was much larger in the subgroup of 6,247 patients who were not on dialysis at the time of randomization (22% risk reduction) than in the subgroup of  3,023 patients who were receiving dialysis at the time of randomization (6% risk reduction).

The committee did not vote on an indication that would have included the entire pre-dialysis and dialysis population included in SHARP. One veteran FDA observer, Michael McCaughan, a reporter for The RPM Report, tweeted his belief that the committee would have voted in favor if there had been such a vote.

The panel also had no concerns about safety issues associated with Vytorin.

Merck sent the following statement to CardioBrief:

“We are pleased with the panel’s recommendation and will continue working with the FDA on its evaluation of the proposed indications for ZETIA and VYTORIN.  If approved for these uses, these medicines have the potential to help to address a significant, unmet need among people with chronic kidney disease,” said Peter S. Kim, Ph.D., president, Merck Research Laboratories.  “The Advisory Committee vote brings ZETIA and VYTORIN one step closer to being an option for these patients who are at increased risk for cardiovascular events and procedures.”

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