FDA issues CRL on Merck's Zetia and Vytorin sNDA

16 February 2016

The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding pharma giant Merck & Co's (NYSE: MRK) supplemental New Drug Applications for Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), rejecting the claim that the combination therapy reduces the risk of heart attacks and strokes.

The sNDA was 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 said it is reviewing the letter and will determine next steps.

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