Add to balance / Manage account | User: | Log out |
Prospect News home > News index > List of issuers S > Headlines for Schering-Plough Corp. > News item |
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.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.