Sanofi-aventis and Bristol-Myers Squibb Company announced 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 300 mg tablet of the antiplatelet Plavix (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 300 mg 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 (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.
Sanofi-aventis and Bristol-Myers Squibb are committed to 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 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.
Plavix is an antiplatelet agent which prevents platelets from sticking together and forming clots in the arteries and is the only widely available prescription antiplatelet approved to reduce the risk of heart attack and stroke across the entire spectrum of ACS.
Plavix is indicated for the reduction of atherothrombotic events in patients with a history of recent MI, recent stroke or established peripheral arterial disease (P.A.D.) Plavix is also indicated for patients with NSTEMI ACS, including those who are to be managed medically and those managed with PCI (with or without a stent) or CABG. Additionally Plavix is indicated in STEMI patients.
Plavix is marketed worldwide by sanofi-aventis and Bristol-Myers Squibb Company as Plavix and Iscover.