Sanofi-aventis (SNY) announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the anticoagulant Lovenox(R) (enoxaparin sodium injection) for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
Lovenox(R) has been shown to reduce the rate of the combined endpoint of recurrent myocardial infarction or death in patients with acute STEMI receiving thrombolysis and being managed medically or with Percutaneous Coronary Intervention (PCI).
STEMI is a severe type of heart attack in which an artery is generally completely blocked by blood clot for sufficient time causing heart muscle damage.
The FDA approval is based on the results of the landmark ExTRACT-TIMI 25 trial (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial InfarCtion Treatment, Thrombolysis In Myocardial Infarction – 25 Study), which included more than 20,000 acute STEMI patients and the results of which were published in the April 6, 2006 edition of the New England Journal of Medicine.
“The FDA approval is a significant milestone in the evaluation of treatment options of patients with STEMI,” said Elliott Antman, M.D., Senior Investigator TIMI Study Groups, Director, Samuel A. Levine Cardiac Unit at Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study. “With its new indication, enoxaparin is now applicable across the full spectrum of acute coronary syndrome conditions including unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) and ST-segment elevation myocardial infarction (STEMI).”
Sanofi-aventis has also submitted a dossier for the STEMI indication in European countries including France, Germany, UK, Italy and Spain.