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ARTICLE | Clinical News

Zetia ezetimibe regulatory update

February 22, 2016 8:00 AM UTC

Merck said FDA issued a complete response letter for sNDAs that were seeking to add claims of cardiovascular benefit to the labels of Vytorin ezetimibe/simvastatin and Zetia ezetimibe. The pharma markets the drugs to reduce elevated cholesterol in patients with hyperlipidemia and related conditions.

In December, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 that data did not show that adding Zetia to a statin reduced the risk of CV events compared with a statin alone. Merck based its sNDAs on data from the Phase III IMPROVE-IT trial in high-risk patients presenting with acute coronary syndrome (ACS), in which Vytorin patients had a 6.4% relative risk reduction on the primary composite endpoint vs. simvastatin alone. The treatment difference was primarily driven by non-fatal MI and non-fatal stroke, and panelists were concerned about the magnitude of the observed clinical benefit, clinical effect of components that drove the endpoint and missing data that could have skewed the results. ...