Merck can not claim that its cholesterol-lowering drug Vytorin reduces the risk of heart attacks and strokes in patients with coronary heart disease, concluded an FDA advisory panel.
The results of Merck's 18,000-patient trial showed that Vytorin, a combo treatment of Zetia and an older cholesterol-lowering drug, simvastatin, reduced the rates of heart attack, stroke and death by 6.4% compared with simvastatin alone.
The panel, who voted 10-5 against the label update, was not convinced that outcome demonstrated "clinically meaningful" benefits.
Merck says they will continue to work with the FDA so that the agency can complete its review of the drugmaker's request for new indications for Vytorin and Zetia.
Read the Reuters article