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.
Outside Japan, Plavix(R) is the only widely approved antiplatelet agent used in monotherapy for prevention of atherothrombotic events in patients with recent myocardial infarction (hear attack), recent ischaemic stroke or established peripheral arterial disease, and in combination with acetylsalicylic acid for the treatment of patients with acute coronary syndrome (unstable angina or NSTEMI) including those who are to be managed medically and those managed with PCI (with or without stent) and for STEMI patients.
Plavix(R) is one of the most studied cardiovascular medications available to patients with short and long term clinical benefit, and after a decade of prescriptions, it remains the oral antiplatelet therapy with the broadest range of indications worldwide.
Plavix(R), also marketed as Iscover(R), is an antiplatelet agent which prevents platelets from sticking together and forming clots in the arteries. Plavix(R) was first authorized in the United States in 1997 and the European Union in 1998 and has been prescribed to more than 70 millions patients worldwide.
In Japan, in addition to the new approval for acute coronary syndrome (unstable angina pectoris, non-ST elevation myocardial infarction) for which percutaneous coronary intervention (PCI) is planned, Plavix(R) is also approved for "reduction of recurrence after ischemic cerebrovascular disorder (excluding cardiogenic cerebral embolism)" one of the 3 major causes of death in Japan.
The efficacy and safety profile of Plavix(R) have been established through landmark clinical trials including more than 100,000 patients worldwide. Outside Japan, Plavix(R) has shown favourable tolerability profile as compared to ASA and an acceptable increase in major bleedings when used in combination with ASA (no statistical difference when only PCIs are considered).
In Japan, Plavix(R) is marketed by sanofi-aventis K.K. Plavix(R) is marketed in more than 100 countries by sanofi-aventis (Paris Bourse: EURONEXT: SAN; New York: NYSE: SNY) and BMS (NYSE: BMY).
About Acute Coronary Syndrome
Acute coronary syndrome (ACS) is an umbrella term used to describe a group of clinical diagnoses caused by narrowing of the coronary arteries and covers any group of clinical symptoms compatible with acute myocardial ischemia, caused by an imbalance between myocardial oxygen supply and demand from coronary artery disease.
Unstable angina, non-ST segment elevation myocardial infarction (myocardial infarction which does not show ST elevation in ECG), and acute myocardial infarction are considered to be the series of the pathological condition referred to as acute myocardial ischemia as the clinical syndrome. These three symptoms and sudden cardiac death are collectively referred to as acute coronary syndrome.
Immediate treatment is required for all ACS. The treatment approach is multifaceted and aims to try and protect the affected heart muscle from further damage, reinstate blood flow through the artery and reduce the heart's demand for oxygen. Restoration of blood to the heart (reperfusion) can be achieved either via the use of certain drugs (fibrinolytics), used to break down blood clots, or mechanically by surgery (i.e. Percutaneous Coronary Intervention (PCI)]. Pharmacological options for the treatment ACS include the use of antiplatelet agents to help prevent platelets from sticking together and forming clots, and anticoagulants to prevent blood clotting. Anticoagulants prevent clots from growing and new ones from forming, but they do not dissolve clots.
Atherothrombosis is the underlying cause of life-threatening events such as heart attacks and ischemic stroke. It is a progressive disease process in which there is an unpredictable and sudden rupture of an atherosclerotic plaque. The rupture, fissure or erosion of these plaques activates platelets in the blood to form a clot (thrombus) and which can partially or completely block arteries, resulting in atherothrombotic events.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
1 Guidelines for Management of Acute Coronary Syndrome without Persistent
ST segment Elevation (JCS 2002, Circulation Journal Vol.66, Suppl. IV.
2 Guidelines for management of anticoagulant and antiplatelet therapy in
cardiovascular disease (JCS 2004, Circulation Journal Vol.68, Suppl. IV,
3 The American College of Cardiology/The American Heart Association
4 ACC/AHA 2007 Guidelines for the Management of Patients With Unstable
Angina/Non-ST-Elevation Myocardial Infarction: Circulation 116: 803 -
5 The American College of Cardiology/The American Heart Association/The
Society of Cardiovascular Angiography and Interventions
6 ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary
Intervention: Circulation 113(7): e166 - e286, 2006
7 The European Society of Cardiology
8 Guidelines for the diagnosis and treatment of non-ST-segment elevation
acute coronary syndromes: Eur Heart J. 28(13): 1598-1660, 2007
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