Plavix® (clopidogrel)

Plavix® is an anti-thrombosis drug, more specifically known as an antiplatelet agent. It is indicated for the prevention of atherothrombotic complications in patients with a recent history of myocardial infarction, recent stroke, or established peripheral arterial disease. Plavix® is currently the only medicine indicated for the secondary prevention of atherothrombosis regardless of the location of the primary arterial damage.

This indication is supported by the decisive results of the CAPRIE study on nearly 20,000 patients which demonstrated the superior efficacy of Plavix® compared to acetylsalicylic acid (ASA, the active ingredient of aspirin) with equivalent tolerability.

Following the impressive results obtained in the CURE study in 2002, Plavix® obtained an extended indication for the treatment of acute coronary syndrome (non-Q myocardial infarction and unstable angina) in combination with aspirin. This indication was included in the recommendations of the American Heart Association, the American College of Cardiology and the European Society of Cardiology. On top of standard therapy, including aspirin, Plavix® reduced by 20% the relative risk of atherothrombotic events with a 1% increase of major bleeding occurrences.

The CLARITY-TIMI 28 study showed that Plavix® added to standard therapy including fibrinolytics and aspirin reduced the odds of acute myocardial infarction patients having another occluded artery, or a second heart attack or death after one week of hospitalization.

The COMMIT/CCS-2 study, one of the most extensive studies worldwide, involving over 46,000 patients, demonstrated that Plavix® in combination with standard treatments, aspirin in particular, reduces the high incidence of death 28 days after an acute myocardial infarction. severe bleeding. These patients represented close to 80% of the total CHARISMA population.

In the last two studies, the incidence of severe bleeding was similar in the Plavix® and placebo groups, thereby demonstrating a favorable benefit/ risk ratio for Plavix®. On the basis of these results, the US Food and Drug, Administration decided on January 18, 2006, to grant Plavix® a priority review for a supplemental new drug application (sNDA) in a new indication: acute phase myocardial infarction.

Plavix® was launched in 1998. It is currently marketed in over 80 countries, including the United States, through an alliance with Bristol-Myers Squibb (BMS). In Japan, an application for marketing approval was accepted in January 2006 and launch is planned for this year. Plavix® sales in Japan are not covered by our alliance with BMS.