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news.The US Food and Drug Administration (FDA) has turned down Merck's supplemental new drug applications for Zetia and Vytorin for the reduction of the risk of cardiovascular events in patients with coronary heart disease.
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Merck received a complete response letter from the agency. The company said it will review the letter and determine its next steps.
The applications were based on the results of improved reduction of outcomes: vytorin efficacy international trial.
The FDA approved Zetia in 2002 and Vytorin in 2012. They are indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia.
The effect of Zetia on cardiovascular morbidity and mortality has not been determined.
Vytorin features two active ingredients which include ezetimibe and simvastatin. Merck said no incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Zetia should be administered alone or in combination with a statin. It is indicated as adjunctive therapy to diet to lower elevated total cholesterol, LDL cholesterol, apolipoprotein B, and non-HDL cholesterol in patients with primary hyperlipidemia when diet alone is not enough.
Vytorin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol, and to increase HDL cholesterol in patients with primary hyperlipidemia or mixed hyperlipidemia when diet alone is not enough.