FDA rejects request from Merck Inc., for Vytorin (ezetimibe + simvastatin) and Zetia (ezetimibe) label to include the reduction of cardiovascular events.
Merck Inc. announced that the FDA has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for Zetia (ezetimibe) and Vytorin (ezetimibe + simvastatin) for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease. The applications were based on the results of IMPROVE-IT (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial). Merck is reviewing the letter and will determine next steps.
Zetia and Vytorin 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 contains 2 active ingredients: ezetimibe and simvastatin. No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.
Comment:In 2015 an FDA Advisory Committee rejected the claim from Merck Inc. that Vytorin reduces cardiovascular risk events.
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