FDA priority review for Sanofi's Lovenox in STEMI
The Food and Drug Administration has accepted for review a supplemental New Drug Application for Sanofi-Aventis' anticoagulant Lovenox (enoxaparin sodium injection) for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI), a type of acute heart attack.
STEMI is a heart attack in which an artery is generally completely blocked with a clot 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 or marketed products. The company has also submitted a filling in European countries including France, Germany, UK, Italy and Spain.
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