EMEA Approves Plavix Loading Dose for ACS Patients


March 6, 2008

March 5, 2008 - 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 300 mg tablet of the antiplatelet Plavix (clopidogrel bisulfate), a treatment intended to promote early use of Plavix in acute coronary syndrome patients (ACS).

Sanofi-aventis and Bristol-Myers Squibb said that the new 300 mg tablet is designed to facilitate the use of the approved loading dose of Plavix and the early initiation as recommended by national and international guidelines in appropriate patients with 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 300 mg tablet is bioequivalent to four 75 mg tablets of Plavix, according to the manufacturers.

The opinion by the EMEA, however, still requires ratification by the European Commission in the coming months before final approval.

Sanofi-aventis and Bristol-Myers Squibb will continue studying the Plavix loading dose in ACS patients managed with an early invasive strategy in the ongoing large international clinical trial known as 'CURRENT'. CURRENT is a randomized controlled trial designed to investigate in 14,000 patients, whether the use of a clopidogrel 600mg loading dose, followed by an intensified clopidogrel dosing regimen (six days at 150 mg follow by 75 mg) yields improved clinical outcomes as compared to clopidogrel 300 mg loading dose followed by 75 mg 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 companies expect to have results by the end of 2008.

For more information: www.plavix.com