sanofi-aventis and Bristol-Myers Squibb Co. announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application for Plavix (clopidogrel bisulfate) to reduce the rate of death from any cause and the rate of a combined endpoint of re-infarction, stroke or death in patients with acute ST-segment elevation myocardial infarction (STEMI).
STEMI is a severe acute heart attack in which a coronary artery is generally blocked completely. These blockages are caused by clot formation in the arteries, a life-threatening complication of an underlying disease known as atherothrombosis, a company release stated.
Plavix is a prescription antiplated medicine taken once a day that helps platelets in the blood from sticking together and forming clots. Since initial approval on November 17, 1997, the US Food and Drug Administration, Plavix has been prescribed to more than 52 million patients worldwide.
Plavix is marketed worldwide by sanofi-aventis and Bristol-Mayers Squibb Co as Plavix and Iscover.
"Clopidogrel taken with aspirin has previously been shown to reduce the risk of death, recurrent heart attacks or stroke in patients with unstable angina or less severe heart attacks," said Marc Sabatine, TIMI Study Group, Brigham and Women's Hospital. "Now, based on the positive results of two clinical trials, COMMIT and CLARITY-TIMI 28, clopidogrel has been approved by the FDA for use with aspirin in patients with the most severe types of heart attacks, thereby extending the benefit of clopidogrel to patients across the spectrum of acute coronary syndromes," Marc Sabatine added.
The US FDA approval was based on the results of two clinical trials of more than 48,000 patients in which STEMI patients treated with Plavix taken with aspirin and standard therapy were compared to STEMI patients treated with placebo taken with aspirin and standard therapy.
In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) trial conducted in China, patients were followed for up to 28 days while in the CLARITY - TIMI 28 (CLopidogrel as Adjunctive ReperfusIon TherapY - Thrombolysis In Myocardial Infarction Study 28) multi-national trial, patients were followed for 30 days.
Results of the COMMIT/CCS-2 trial demonstrated that in the 28 days following randomization, clopidogrel, taken with aspirin and standard therapy, reduced the relative risk of death in STEMI patients by 7 per cent, and reduced the relative risk of the combination of MI, stroke, or death by 9 per cent.
In the CLARITY - TIMI 28 trial, clopidogrel taken with aspirin and other standard therapy including thrombolytics significantly reduced the odds of STEMI patients having another occluded artery, or a second heart attack or death by 36 per cent by day eight of hospitalization or discharge.
sanofi-aventis and Bristol-Myers stated that data from the COMMIT/CCS-2 and CLARITY - TIMI 28 trials have also been submitted to the European Medicines Evaluation Agency (EMEA) for a STEMI indication in the European Union, and recently received a positive opinion from the agency's Committee for Medicinal Products for Human Use (CHMP).