New 300mg Loading Dose Tablet for Plavix(R) Receives Positive Opinion From the European Committee for Medicinal Products (CHMP)
- A New Step Forward May Help Increase Appropriate Early Use of Plavix(R)by Simplifying Administration in Acute Coronary Syndrome Patients
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers SquibbCompany (NYSE: BMY) announced today that the Committee for Medicinal Productsfor Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) hasissued a positive opinion recommending approval of the 300mg tablet of theantiplatelet Plavix(R) (clopidogrel bisulfate). This positive opinion fromthe CHMP needs to be ratified by the European Commission in the coming monthsbefore final approval.
The new 300mg tablet will facilitate the use of the approved loading doseof Plavix(R) and the early initiation as recommended by national andinternational guidelines in appropriate patients with acute coronary syndrome(ACS), including those with unstable angina / non-ST segment elevationmyocardial infarction (managed with percutaneous intervention (PCI) with orwithout stent or medically managed) and ST segment elevation myocardialinfarction patients. The 300mg tablet is bioequivalent to four 75mg tabletsof Plavix(R).
Sanofi-aventis and Bristol-Myers Squibb are committed to further studyingthe optimization of the Plavix(R) loading dose in ACS patients managed withan early invasive strategy in the ongoing large international clinical trialknown as 'CURRENT'. CURRENT is the only randomized controlled trial designedto investigate in 14000 patients, whether the use of a clopidogrel 600mgloading dose, followed by an intensified clopidogrel dosing regimen (6 daysat 150mg follow by 75mg) yields improved clinical outcomes as compared toclopidogrel 300mg loading dose followed by 75mg in ACS patients managed withan early invasive strategy. The primary endpoint of CURRENT is the reductionof a composite endpoint of cardiovascular death, stroke and myocardialinfarct (MI) and the results are expected by the end of 2008.
Plavix(R) is an antiplatelet agent which prevents platelets from stickingtogether and forming clots in the arteries and is the only widely availableprescription antiplatelet approved to reduce the risk of heart attack andstroke across the entire spectrum of ACS.
Plavix(R) is indicated for the reduction of atherothrombotic events inpatients with a history of recent MI, recent stroke or established peripheralarterial disease (P.A.D.) Plavix(R) is also indicated for patients withNSTEMI ACS, including those who are to be managed medically and those managedwith PCI (with or without a stent) or CABG. Additionally Plavix(R) isindicated in STEMI patients.
For ACS patients, European Guidelines (ESC Guidelines for NSTEMI ACS2007) recommend pre-treatment of unselected patients with Plavix(R) beforeangiography results for better outcome of PCI.
The early and long term efficacy and safety profile of Plavix(R) is wellestablished in clinical trials involving more than 100,000 patients acrossthe full spectrum of ACS, recent MI, recent ischemic stroke and establishedP.A.D, with real-world experience since its launch in more than 70 millionpatients worldwide.
Plavix(R) is marketed worldwide by sanofi-aventis and Bristol-MyersSquibb Company as Plavix(R) and Iscover(R).
Sanofi-aventis, a leading global pharmaceutical company, discovers,develops and distributes therapeutic solutions to improve the lives ofeveryone. Sanofi-aventis is listed in Paris (EURONEXT PARIS: SAN) and in NewYork (NYSE: SNY).
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
Forward Looking Statements
This press release contains forward-looking statements a
You May Also Like