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Plavix(R) Indications Expanded in Japan to Include Patients with Acute Coronary Syndrome for Whom Percutaneous Coronary Intervention Is Being Planned
Date:10/21/2007

PARIS, Oct. 21 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for a Supplemental New Drug Application (sNDA) for the indication of "Acute coronary syndrome (unstable angina pectoris, non-ST elevation myocardial infarction) for which percutaneous coronary intervention (PCI) is being planned" for Plavix(R) (clopidogrel).

Approximately 100,000 patients develop an acute coronary syndrome (ACS) and elect to undergo PCI every year in Japan -- where Plavix(R) is now the first drug approved in this indication --, the largest number of patients in the world outside of the United States. "We are pleased that the innovative therapy, Plavix(R) is now available to physicians in Japan, offering them a new treatment option with proven outcomes and safety across ACS patients with planned PCI," said Hanspeter Spek, Executive Vice-President Pharmaceutical Operation of sanofi-aventis.

In Japan, this new cardiology (ASC) extension completes the recent approval (May 2006) in the reduction of recurrence of stroke for which the 2 weeks-prescription-only-limitation has been lifted in May 2007, as result of the favorable one year safety assessment.

The efficacy and safety profile of Plavix(R) is well established in multiple large-scale Japanese and international landmark clinical trials involving more than 100,000 patients as well as from real-life clinical experience in more than 70 millions patients worldwide including Japan.

Japanese guidelines(1, 2) suggest that Plavix(R) can fill an important medical need for patients with UA-NSTEMI. Outside Japan, Plavix(R) is also recommended in multiple national and international guidelines (US [ACC/AHA] and European [ESC]) (3,4,5,6,7,8) for ACS, heart attack, recent MI, stroke and/or P.A.D patients at risk for future atherothrombotic events as a standard treatment for millions of patients at cardiovascular risk.

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