FDA Rejects New Indication for Zetia and Vytorin

Merck has received a complete response letter from the FDA regarding its supplemental new drug applications for ezetimibe (Zetia) and ezetimibe and simvastatin (Vytorin).

Merck hoped to expand the indications for Zetia and Vytorin so that they could be used for reducing the risk of cardiovascular events (eg, cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary artery disease.

The supplemental new drug applications for Zetia and Vytorin included clinical trial data from the Improved Reduction of Outcomes: Vytorin Efficacy International Trial.

In a statement, Merck said it was reviewing the FDA’s complete response letter and would determine the next steps.

Zetia's effects on cardiovascular morbidity and mortality have not been determined.

Zetia and Vytorin are already approved to reduce elevated low-density lipoprotein cholesterol in patients with hyperlipidemia, alongside a healthy diet.