To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: FDA Panel's Vote Over Weight-Loss Drug Xenical Results in Tie URL: http://www.pslgroup.com/dg/61ECE.htm Doctor's Guide March 16, 1998
BASEL, SWITZERLAND -- March 16, 1998 -- The United States Food and Drug Administration's endocrinologic and metabolic drugs advisory committee is deadlocked at five to five on recommending approval of F. Hoffmann-La Roche Ltd.'s weight management drug Xenical(R) (orlistat). Roche said it would meet shortly with the FDA staff to discuss the recommendation. Roche reaffirms its belief that orlistat has an important role to play in the management of obesity and looks forward to discussing next steps with the FDA. In May 1997 the panel unanimously recommended the approval of Xenical, a lipase inhibitor which acts in the gastrointestinal tract to decrease fat absorption by about 30 percent. Drugs in this class do not achieve their effect through brain chemistry. Previous studies showed that Xenical-treated patients had statistically significant reductions in total and LDL cholesterol and systolic and diastolic blood pressure, as well as improvements in blood concentrations of glucose and insulin after one year over placebo with diet. More information on: Hoffmann-La Roche and, More information on: Xenical --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.