New 300mg Loading Dose Tablet for Plavix Receives Positive Opinion From the European Committee for Medicinal Products (CHMP)

March 05, 2008 /PRNewswire-FirstCall/ --Sanofi-aventis and Bristol-Myers Squibb Company announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of the 300mg tablet of the antiplatelet Plavix(R) (clopidogrel bisulfate). This positive opinion from the CHMP needs to be ratified by the European Commission in the coming months before final approval.

The new 300mg tablet will facilitate the use of the approved loading dose of Plavix(R) and the early initiation as recommended by national and international guidelines in appropriate patients with acute coronary syndrome (ACS), including those with unstable angina / non-ST segment elevation myocardial infarction (managed with percutaneous intervention (PCI) with or without stent or medically managed) and ST segment elevation myocardial infarction patients. The 300mg tablet is bioequivalent to four 75mg tablets of Plavix(R).

Sanofi-aventis and Bristol-Myers Squibb are committed to further studying the optimization of the Plavix(R) loading dose in ACS patients managed with an early invasive strategy in the ongoing large international clinical trial known as 'CURRENT'. CURRENT is the only randomized controlled trial designed to investigate in 14000 patients, whether the use of a clopidogrel 600mg loading dose, followed by an intensified clopidogrel dosing regimen (6 days at 150mg follow by 75mg) yields improved clinical outcomes as compared to clopidogrel 300mg loading dose followed by 75mg in ACS patients managed with an early invasive strategy. The primary endpoint of CURRENT is the reduction of a composite endpoint of cardiovascular death, stroke and myocardial infarct (MI) and the results are expected by the end of 2008.