Acute ST-segment elevation myocardial infarction is a heart attack in which an artery is generally completely blocked by clot formation for sufficient time to cause heart muscle damage.
The FDA has designated the filing for priority review, which is granted to applications in which a new indication or new drug product, if approved, would present a significant improvement compared to currently available therapies. The company as also submitted a filing in European countries including France, Germany, UK, Italy and Spain.
Lovenox is a low-molecular weight heparin approved in 96 countries with seven indications for the prophylaxis and treatment of thromboembolic disease, including prophylaxis of ischemic complications of unstable angina and non-Q-wave (non-ST-segment elevation) myocardial infarction and the prophylaxis of deep-vein thrombosis (DVT), a condition that may lead to pulmonary embolism (PE).