FDA approves new indication for Merck/Schering-Plough's cholesterol-lowering drug

By Lisa Kerner

Charlotte, N.C., June 9 - The Food and Drug Administration has approved Merck/Schering-Plough Pharmaceuticals' Zetia (ezetimibe) for use in combination with fenofibrate for the reduction of elevated total cholesterol and LDL (bad) cholesterol in patients with the metabolic disorder, mixed hyperlipidemia.

Zetia's unique mechanism of action inhibits the intestinal absorption of cholesterol, according to a company news release.

FDA approval was based on a clinical trial in which the combination therapy of 10 mg of Zetia co-administered with 160 mg of fenofibrate reduced LDL cholesterol levels by 20% compared to 6% with 160 mg fenofibrate as monotherapy and a 13% with 10 mg Zetia alone.

A total of 625 patients with mixed hyperlipidemia were treated for up to 12 weeks, with 576 of the patients continuing treatment for up to an additional 48 weeks.

Merck/Schering-Plough Pharmaceuticals is a joint venture between Merck & Co., Inc., based in Whitehouse Station, N.J., and Schering-Plough Corp., located in Kenilworth, N.J., formed to develop and market in new prescription medicines in cholesterol management.

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