November 3rd, 2011
FDA Advisory Committee Recommends Approval of Vytorin for Pre-Dialysis CKD Patients
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Wednesday 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 Vytorin for 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 with Vytorin compared with placebo. However, the beneficial effect was much larger in the subgroup of 6247 patients who were not on dialysis at the time of randomization (22% risk reduction) than among the 3023 patients who were receiving dialysis at 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.