Sanofi-Aventis drug ‘applicable for all acute coronary conditions’

Sanofi-Aventis has announced an extension of the indication of Lovenox (enoxaparin sodium injection) to include being a therapy for ST-segment elevation myocardial infarction (Stemi) – a condition where an artery is blocked for sufficient time to result in damage to heart muscle.

Clinical trials have shown the compound to lower the rate of recurrent myocardial infarction and death in patients suffering acute Stemi on thrombolysis who are receiving percutaenous coronary intervention or otherwise having their condition managed medically.

Based on the positive results of the enoxaparin and thrombolysis reperfusion for acute myocardial infarction treatment, thrombolysis in myocardial infarction – 25 (ExTract-Timi 25) trial, the compound has had its supplemental new drug application approved by the US Food and Drug Administration.

Elliot Antman, senior investigator of the Timi study groups, said: “With its new indication, enoxaparin is now applicable across the full spectrum of acute coronary syndrome conditions including unstable angina or non-Stemi and Stemi.”

He added that this approval from the FDA marked a significant landmark in the progress of Stemi patients, while the company reports that it has submitted data for this indication in a number of EU countries, including the UK.

The company had previously been granted a priority review for Lovenox by the FDA in February 2007.