Sanofi-aventis announced that the Japanese Ministry of Health Labour and Welfare (MHLW) has accepted for priority review a supplemental new drug application (sNDA) for the antiplatelet drug Plavix (clopidogrel bisulfate). The sNDA was filed for reducing vascular event risk in patients with Acute Coronary Syndrome (ACS) for whom the application of percutaneous coronary intervention (PCI) is considered (generally, unstable angina, non-ST segment elevation myocardial infarction).

The MHLW has designated the filing for priority review, which is generally granted to applications in which a new indication or new drug product, if approved, would present a significant improvement as compared to currently available therapies or marketed products.

In Japan, guidelines published by the Japanese Circulation Society have expressed an interest in the early approval of Plavix for treatment of patients with acute coronary syndrome and treatment of cardiovascular patients with anticoagulant/antiplatelet therapy. This suggests that Plavix is recognized as a drug that can fill an important medical need.

Since May 2006, Plavix has been marketed in Japan as antiplatelet drug for the reduction of recurrence in patients after ischemic cerebrovascular disorder (excluding cardiogenic cerebro-embolism).

Plavix is an antiplatelet agent which prevents platelets from sticking together and forming clots in the arteries. Worldwide, Plavix also marketed as Iscover has been approved outside Japan for prevention of atherothrombotic events in patients with recent myocardial infarction, recent ischaemic stroke or established peripheral arterial disease and in combination with acetylsalicylic acid (ASA), for the treatment of patients with non-ST (unstable or non-Q-wave MI) and ST segment elevation acute coronary syndrome.

Plavix was first authorized in the United States in 1997 and in the European Union in 1998 and has been prescribed to more than 65 million patients worldwide. The efficacy and safety profile of Plavix have been established through landmark clinical trials including more than 100 000 patients.

Plavix is marketed in 85 countries by sanofi-aventis and Bristol-Myers Squibb Company. In Japan Plavix is marketed by sanofi-aventis k.k.

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 it is these clots which can partially or completely block arteries, resulting in atherothrombotic events.

Acute coronary syndrome (ACS) is an umbrella term used to describe a group of clinical diagnoses caused by narrowing of the coronary arteries and cover any group of clinical symptoms compatible with acute myocardial ischemia, caused by an imbalance between myocardial oxygen supply and demand from coronary artery disease. 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.