In the USA, Rhone-Poulenc Rorer has filed a supplemental New DrugApplication for its low molecular weight heparin product Lovenox (enoxaparin sodium) in a bid to market the drug for patients with unstable angina and non-Q-wave myocardial infarction.
Enoxaparin is already marketed for deep vein thrombosis, but an angina indication would greatly increase the potential market for the drug. It is the only antithrombosis agent to be proven in clinical trials to be superior to unfractionated heparin in angina.
The sNDA is based on the results of the ESSENCE study (Marketletter November 25, 1996), which found that enoxaparin was more effective than heparin in reducing a combined endpoint of death, myocardial infarction or recurrent chest pain in patients with unstable angina or non-Q-wave MI.
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