CHMP approves new 300mg loading dose tablet of Plavix

French drug major Sanofi-Aventis and US marketing partner Bristol-Myers Squibb say 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 their antiplatelet drug Plavix (clopidogrel bisulfate).

According to the firms, the new tablet will 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 acute coronary syndrome, including those with unstable angina/non-ST segment elevation myocardial infarction managed with percutaneous intervention with or without stent, or in medically-managed and ST segment elevation myocardial infarction patients.

The two drug majors are further studying the optimization of the Plavix loading dose in ACS patients managed with an early invasive strategy in the ongoing large international clinical trial. The CURRENT study, which is investigating in 14,000 patients, whether the use of a clopidogrel 600mg loading dose, followed by an intensified clopidogrel dosing regimen (six days at 150mg followed 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 is the reduction of a composite endpoint of cardiovascular death, stroke and myocardial infarct and the results are expected by the end of the year.