The Committee for Medicinal Products for Human Use of the European Medicines Evaluation Agency has issued a positive opinion recommending approval of the 300mg tablet of the antiplatelet Plavix (clopidogrel bisulfate) from Sanofi-aventis and Bristol-Myers Squibb (BMS).
The positive opinion from the CHMP needs to be ratified by the European Commission in the coming months before final approval, according to the companies.
The new 300mg tablet will facilitate the use of the approved loading dose of Plavix and the early initiation as recommended by national and international guidelines in patients with acute coronary syndrome (ACS), including those with unstable angina /non-STEMI and STEMI patients, according the Paris-based Sanofi-aventis and the New York City based BMS.
The 300mg tablet is bioequivalent to four 75mg tablets of Plavix.
Sanofi-aventis and Bristol-Myers Squibb also reported that they are committed to further studying the optimization of the Plavix loading dose in ACS patients managed with an early invasive strategy in the ongoing international clinical trial, CURRENT.
The trial is the only 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 (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 companies said.
The primary endpoint of CURRENT is the reduction of a composite endpoint of cardiovascular death, stroke and MI; and the results are expected by the end of 2008.