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FDA Grants Priority Review to Supplemental New Drug Application for Plavix (Clopidogrel) PARIS, FRANCE and PRINCETON, NJ -- September 10, 2001 -- Sanofi-Synthelabo and Bristol-Myers Squibb Company today announced that the supplemental new drug application (sNDA) for Plavix® (clopidogrel bisulfate) has been granted priority review by the U.S. Food and Drug Administration (FDA). Under priority review, new drug applications are reviewed within six months. The supplemental filing for clopidogrel is based on the positive results of the landmark CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) study, recently published in the New England Journal of Medicine(1). The CURE trial demonstrated that initiating therapy early with clopidogrel, on top of standard therapy including ASA (aspirin), and continuing its use long term, significantly reduced the risk of heart attack, stroke and cardiovascular death by 20 percent in patients with acute coronary syndrome (unstable angina and non-Q wave myocardial infarction) (p = 0.00009) compared with patients who received standard therapy (including ASA) alone. In the study, the benefits of clopidogrel were seen within hours and continued to increase throughout the entire study duration of 12 months. The CURE results also confirmed clopidogrel's overall safety profile. The risk of major bleeding was 3.7 percent when clopidogrel was used on top of standard therapy (including ASA), compared to 2.7 percent with standard therapy (including ASA) alone. Plavix is currently indicated for the reduction of atherosclerotic events (myocardial infarction, stroke, and vascular death) in patients with atherosclerosis documented by recent stroke, recent myocardial infarction, or established peripheral arterial disease. Plavix is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. As part of the worldwide postmarketing experience with Plavix, suspected cases of thrombotic thrombocytopenic purpura (TTP) have been reported at a rate of about four cases per million patients exposed. See WARNINGS in full prescribing information. In the CAPRIE (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) study, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4 percent) and severe neutropenia (0.04 percent). References: 1. The CURE Trial Investigators. Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation. N Engl J Med 2001;345:494-502. SOURCE: Sanofi-Synthelabo E-mail this page to a friend or colleague! To print, use this version