FDA denies claims for Zetia, Vytorin

February 17, 2016

FDA declined to approve Merck’s claim that its cholesterol-lowering drugs Zetia and Vytorin reduce the risk of heart attacks and strokes in patients with coronary heart disease.

FDA declined to approve Merck’s claim that its cholesterol-lowering drugs Zetia and Vytorin reduce the risk of heart attacks and strokes in patients with coronary heart disease.

While 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” by FDA, according to a Merck statement.

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In addition, “no incremental benefit of Vyotrin on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin [Zocor] has been established”, according to the statement.

FDA's decision follows a recommendation in December by one of its advisory committees that Merck should not be allowed to claim that Vytorin (ezetimibe/simvastatin) reduces the risk of heart attacks and strokes in patients with coronary heart disease, according to Reuters.

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Merck based its applications for the claims on the results of data from its 18,000-patient Improve-IT study. The study showed that Vytorin, a combination of the off-patent statin drug simvastatin with the active ingredient in Zetia, ezetimibe, beat simvastatin alone at cutting cardiovascular risks by 6.4%.

However, FDA reviewers noted that the reduction in risk was small and limited to certain types of patients, such as the elderly and diabetics.

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