FDA panel rebuffs Vytorin, Zetia CV benefit claim

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 that data did not show that adding Zetia ezetimibe to a statin reduced risk of CV events compared with a statin alone. The panel convened to discuss sNDAs from Merck & Co. Inc. (NYSE:MRK) that would have added claims of CV benefit to the labels of Vytorin ezetimibe/simvastatin and Zetia.

Merck markets both drugs to reduce elevated cholesterol in patients with hyperlipidemia and related conditions. ...