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Merck Fails To Win Zetia/Vytorin CV Risk Reduction Claim

 
• By Donna Young

Merck & Co. failed to convince the FDA to permit the firm to market its cholesterol-lowering medications Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) as therapies to reduce the risk of cardiovascular (CV) events – CV death, nonfatal heart attacks and strokes, hospitalization for unstable angina or the need for revascularization – in patients with coronary heart disease.

Merck & Co. failed to convince the FDA to permit the firm to market its cholesterol-lowering medications Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) as therapies to reduce the risk of cardiovascular (CV) events – CV death, nonfatal heart attacks and strokes, hospitalization for unstable angina or the need for revascularization – in patients with coronary heart disease.

In a brief statement, Merck said it was reviewing the FDA's complete response letter, the details of which the company did not disclose, and would determine next steps.

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