WHITEHOUSE STATION, N.J.— Merck announced Nov. 2 that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck's Vytorin for use in patients with pre-dialysis chronic kidney disease.
The committee's vote was mixed (with the majority not in favor) regarding whether there is sufficient evidence to support approval specifically for patients with end-stage renal disease (ESRD) who are receiving dialysis.
Merck is seeking indications for Vytorin and for Zetia in combination with simvastatin to reduce the risk of major cardiovascular events in patients with chronic kidney disease based on the results of the Study of Heart and Renal Protection (SHARP) trial. Neither product is currently indicated for this use.
The Committee reviewed the results of SHARP, which involved more than 9,000 patients, about two-thirds of whom were pre-dialysis and one-third was undergoing dialysis at study entry. SHARP studied the effect of the ezetimibe/simvastatin 10/20 mg combination tablet (VYTORIN) compared to placebo on the occurrence of major cardiovascular events in patients who, on average, had advanced or end stage chronic kidney disease and who did not have a history of heart attack or coronary revascularization, such as heart bypass surgery. The results of SHARP were published in the June 9 issue of The Lancet.
The Committee's recommendation will be considered by the FDA in its assessment of these investigational uses for Vytorin and Zetia . The FDA is not bound by the Committee's guidance, but takes its advice into account. Currently, Merck's supplemental new drug applications remain under review, with agency action expected in the first quarter of 2012.
"We are pleased with the panel's recommendation and will continue working with the FDA on its evaluation of the proposed new indications for Vytorin and Zetia. 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, PhD, president, Merck Research Laboratories. "The Advisory Committee vote brings VYTORIN and ZETIA one step closer to being an option for these patients who are at increased risk for cardiovascular events and procedures, such as heart attacks, strokes and certain types of heart surgery."
