FDA rejects CV benefit claim for Vytorin, Zetia

Merck & Co. Inc. (NYSE:MRK) 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 both 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 risk of CV events compared with a statin alone. Merck based its sNDAs on data from the IMPROVE-IT trial in high-risk patients presenting with acute coronary syndrome, where Vytorin patients had a 6.4% relative risk reduction on the primary composite endpoint compared with simvastatin alone. ...