To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Clopidogrel Receives European Marketing Approval For Atherosclerotic Events URL: http://www.pslgroup.com/dg/8ED1A.htm Doctor's Guide July 15, 1998
PARIS, FRANCE -- July 15, 1998 -- Sanofi S.A.'s clopidogrel has been approved for marketing in Europe. The product is indicated for the reduction of atherosclerotic events such as myocardial infarction, stroke, vascular deaths in patients with a history of symptomatic atherosclerotic disease defined by ischemic stroke, myocardial infarction or established peripheral arterial disease. Treatment with clopidogrel should begin within a few days to less than 35 days of the event in patients who had a myocardial infarction and within seven days to less than six months in patients who had ischemic stroke. Co-developed by Sanofi and Bristol-Myers Squibb, clopidogrel will be marketed in Europe by the two companies under the names Plavix(R) and Iscover(R). The first European launches will take place this month. Clopidogrel was approved by the United States Food and Drug Administration in late 1997 and has been marketed by Sanofi and Bristol-Myers Squibb in the U.S. since March 1998 under the name Plavix. The clearance to market clopidogrel in Europe was based primarily on the results of the CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) clinical trial, a randomised, double-blind trial that enrolled 19,185 patients who had suffered a recent ischemic stroke, recent heart attack or had established peripheral arterial disease. CAPRIE compared the efficacy and safety of clopidogrel and aspirin in reducing subsequent strokes, heart attacks and other vascular events in patients treated for a period of one to three years. CAPRIE demonstrated the innovative nature of clopidogrel, in that it is the first therapeutic agent proven to reduce the risk of atherothrombosis regardless of the vascular pathway involved (cerebrovascular, cardiovascular or peripheral). Plavix provides a significant improvement in the prevention of recurrent myocardial infarction and stroke or the occurrence of vascular death in patients with atherosclerosis. Where aspirin prevents about a quarter of such events, Plavix prevents about a third. In Europe and North America, one person in 10 aged 50 or older has a history of myocardial infarction, stroke or peripheral arterial disease. Myocardial infarction is the leading cause of death in developed countries, while stroke is the third leading case of death. The CAPRIE study also demonstrated the excellent tolerability of Plavix, showing that patients treated with Plavix had a lower risk of severe gastrointestinal hemorrhage than those treated with aspirin. In the U.S., clopidogrel is contraindicated in patients with active pathologic bleeding or who have shown hypersensitivity to the drug or any component of the drug and should be used with caution in patients with severe liver disease. In CAPRIE, the most common clinically important side effects were dyspepsia, purpura, diarrhea and rash; infrequent events included intracranial hemorrhage (0.4 percent) and severe neutropenia (0.04 percent). More information on: Clopidogrel, Sanofi S.A. --------------------------------------------------------------------------------------------- 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.