Sanofi-Synthelabo: FDA Decision Expands Use of Plavix®
01-Mar-2002
PARIS and PRINCETON, NJ -- FEBRUARY 28, 2002 -- Sanofi-Synthelabo (Paris Bourse: Sicovam code 12057) and Bristol- Myers Squibb Company today announced that the U.S. food and Drug Administration (FDA) has approved the antiplatelet medication Plavix® (clopidogrel bisulfate) for a new indication: Acute Coronary Syndrome (ACS). ACS is defined as unstable angina (chest pain) and non Q-wave myocardial infarction (mild heart attack).
The FDA decision means that for patients with ACS, physicians now have a medication that can further reduce the acute and long-term risk of future heart attack, stroke or cardiovascular death on top of current standard therapy, including aspirin. Plavix is already approved for use in patients with a history of recent heart attack, recent stroke or established peripheral arterial disease (poor circulation in the legs which may cause pain).
Unstable angina and mild heart attack are manifestations of atherothrombosis -- an underlying common cause of heart attack, stroke or cardiovascular death.
The new indication for Plavix is based on the conclusive and positive results of the CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) study, which was published in August 2001 in The New England Journal of Medicine1. In the CURE study of 12,562 patients with ACS, Plavix was compared to placebo, with both groups receiving standard therapy including aspirin. CURE demonstrated that using Plavix significantly reduced the risk of heart attack, stroke or cardiovascular death by 20 percent (P=0.00009) in patients with mild heart attack or unstable angina.
"There are more than 1 million people each year in the United States who will develop ACS who could now benefit from Plavix," says Salim Yusuf, M.D., of McMaster University in Hamilton, Ontario, Canada, principal investigator for the CURE trial. "Based on the CURE results, if Plavix were given to people with ACS, it could reduce the occurrence of tens of thousands of heart attacks, strokes and cardiovascular deaths in the United States each year."
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