FDA Says No to Ezetimibe Secondary-Prevention Indication

February 16, 2016

KENILWORTH, NJ — The US Food and Drug Administration has declined to approve a secondary-prevention indication for ezetimibe (Zetia) and the combination of ezetimibe and simvastatin (Vytorin), their manufacturer, Merck, has announced[1]. Both products are long approved for the more limited indication of reduction of LDL cholesterol.

The FDA decision follows a December, 2015 vote by its Endocrinologic and Metabolic Drugs Advisory Committee not to recommend approval of the expanded indication—reduction of cardiovascular events in patients with established coronary heart disease—after reviewing the results of the IMPROVE-IT trial.

As reported by heartwire from Medscape, many of the panelists had been underwhelmed by the trial as support for the new indication, citing methodologic issues as well as its failure to show a robust clinical advantage over standard therapy.

IMPROVE-IT had randomized >18,000 patients to ezetimibe/simvastatin or the statin alone after they experienced an acute coronary syndrome. Patients getting the combo med showed a statistically significant 6.4% relative risk reduction in the composite end point of CV death, nonfatal MI or stroke, revascularization, or hospitalization.

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