FDA declines to approve new indication for Merck & Co.’s Vytorin, Zetia

US regulators declined to approve a new indication for Merck & Co.’s Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe) to include the prevention of heart attacks and strokes in patients with moderate to severe chronic kidney disease (CKD), the company reported Wednesday. However, the FDA did clear a label update to Vytorin to include results from the SHARP trial, which showed that the product lowered LDL cholesterol in these patients and also reduced major vascular events compared to placebo.

In November, a panel of advisors to the agency unanimously voted to recommend approval of Vytorin to prevent heart attack and stroke in patients with CKD who aren’t on dialysis. However, the advisers voted 10-6 that there was not sufficient evidence to support approval of the drug in patients with CKD currently receiving dialysis treatment.

Merck explained Wednesday that because the SHARP study examined the combination of Zetia and Zocor (simvastatin) compared with placebo, and was “not designed to assess the independent contributions of each drug to the observed effect,” the FDA rejected approval of the new indication for Vytorin and Zetia. The company added that the regulator also declined to allow the study’s efficacy results to be included in the label for Zetia.

Merck noted that in the SHARP trial, which included 9438 patients who had advanced or end-stage CKD, Vytorin lowered LDL cholesterol in patients and major vascular events were reduced in the treatment group compared to placebo.