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As Of Filer Filing As/For/On Docs:Pgs Issuer Agent 1/25/06 Sanofi-Aventis 6-K 1/25/06 4:11 Cleary Gottlieb Ste..LLP
Document/Exhibit Description Pages Size 1: 6-K Report of a Foreign Private Issuer HTML 14K 2: EX-99.1 Miscellaneous Exhibit HTML 19K 3: EX-99.2 Miscellaneous Exhibit HTML 10K 4: EX-99.3 Miscellaneous Exhibit HTML 7K
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| PLAVIX STEMI 180106 -- Converted by SECPublisher 2.1.1.6, created by BCL Technologies Inc., for SEC Filing |
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Jeff Macdonald FDA GRANTS PRIORITY REVIEW TO PLAVIX® (clopidogrel bisulfate) --Filing for STEMI Indication Also Submitted in Europe-- PARIS, France and PRINCETON, NJ, January 18, 2006 – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental new drug application (sNDA) for the antiplatelet agent PLAVIX® (clopidogrel bisulfate) for treatment of patients with acute ST-segment elevation myocardial infarction (STEMI). STEMI is a heart attack in which an artery is generally blocked completely for sufficient time to cause heart muscle damage. This blockage is caused by clot formation in the arteries, which is also known as atherothrombosis. There are approximately ten million heart attacks per year worldwide;1 in the United States alone, the estimated 500,000 STEMI events per year represent one-third of all heart attacks suffered in the country.2 The FDA has designated the filing for priority review, which is granted to applications in which a new indication or new drug product, if approved, would present a significant improve ment compared to currently available therapies or marketed products.3 The companies have also submitted a filing to the European Medicines Evaluation Agency (EMEA) for a STEMI indication in the European Union. PLAVIX is approved for early and long term risk reduction in patients at risk for atherothrombotic events. In the CURE trial, patients with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) were followed for up to one year, and in the CAPRIE trial, patients with recent MI, recent ischemic stroke, or established peripheral artery disease were followed for up to three years. The FDA filing is based on the findings of two recent clinical trials that treated STEMI patients with PLAVIX administered on a background of standard therapy. In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) trial, patients were followed for 30 days. In the CLARITY – TIMI 28 (CLopidogrel as Adjunctive ReperfusIon TherapY - Thrombolysis In Myocardial Infarction Study 28) trial, patients were followed for 28 days. Both studies were presented |
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About STEMI and Acute Coronary Syndrome There are approximately ten million heart attacks per year worldwide;1 in the United States alone, the estimated 500,000 STEMI events per year represent one-third of all heart attacks suffered in the country.2 Patients who have experienced STEMI are at high risk of another heart attack, stroke or death, especially in the first month following the initial STEMI event. About PLAVIX The long-term efficacy and safety of PLAVIX have been established through landmark clinical trials in more than 100,000 patients and in clinical practice in millions of patients treated worldwide. PLAVIX has demonstrated early and long term risk reduction for patients at risk for atherothrombotic events in important clinical trials. In the CURE trial, patients with unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI) were followed for up to one year, and in the CAPRIE trial, patients with recent MI, recent ischemic stroke, or established peripheral artery disease were followed for up to three years. PLAVIX is marketed worldwide by sanofi-aventis (Paris Bourse: EURONEXT: SAN; New York: NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) as Plavix® and Iscover®. For more information on PLAVIX visit www.plavix.com. WHO SHOULD RECEIVE Plavix®(clopidogrel bisulfate)?6 PLAVIX is indicated for the reduction of atherothrombotic events as follows:
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Important Risk Information:
**Please see full prescribing information by visiting www.plavix.com. About sanofi-aventis About Bristol-Myers Squibb References: |
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| This 6-K Filing | Date | Other Filings | ||
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| 11/17/97 | ||||
| 9/5/05 | ||||
| 12/8/05 | ||||
| 1/18/06 | ||||
| Filed On / Filed As Of / For The Period Ended | 1/25/06 | |||
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