sanofi-aventis announced that the Japanese Ministry of Health, Labour 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 (clopidogrel).
Approximately 100,000 patients develop an acute coronary syndrome (ACS) and elect to undergo PCI every year in Japan - where Plavix 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 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, 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 favourable one-year safety assessment. The efficacy and safety profile of Plavix 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 suggest that Plavix can fill an important medical need for patients with Uanstemi.
Outside Japan, Plavix is also recommended in multiple national and international guidelines (US [ACC/AHA] and European [ESC]) 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 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 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 also marketed, as Iscover is an antiplatelet agent, which prevents platelets from sticking together, and forming clots in the arteries. Plavix 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 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 have been established through landmark clinical trials including more than 100 000 patients worldwide. Outside Japan, Plavix 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 is marketed by sanofi-aventis K.K. Plavix is marketed in more than 100 countries by Aventis-aventis
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.