Rhone-Poulenc Rorer's low molecular weight heparin Lovenox/Clexane (enoxaparin sodium) has been approved by the US Food and Drug Administration for a new indication, the prevention of ischemic complications in unstable angina and non-Q-wave myocardial infarction patients.
Enoxaparin is already marketed for the prevention and treatment of deep vein thrombosis in the USA. It has also been approved for UA and non-Q-wave MI in 25 countries outside the USA, including several European countries.
The approval is based on the results of the 3,171-patient ESSENCE study which, when it was first unveiled in November 1996, showed that enoxaparin plus aspirin is more effective than heparin plus aspirin in reducing a combined endpoint of death, myocardial infarction or recurrent ischemia, at 14 days and 30 days, in patients with UA or non-Q-wave MI.
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