August, 8, 2007 - The Medicines Company announced that the new guidelines released yesterday by the American College of cardiology (ACC) and the American Heart Association (AHA) grant a Class I (level of evidence B) recommendation that Angiomax "should be administered" as one of the choices for anticoagulant therapy for patients with unstable angina (UA) and non-ST-elevated myocardial infarction (NSTEMI) who are selected to receive an invasive strategy.
Angiomax is used for patients undergoing percutaneous coronary intervention (PCI), is currently approved commonly referred to as angioplasty. The guidelines note that an invasive strategy should be considered for patients with high-risk characteristics. The guidelines state anticoagulant therapy should be given with antiplatelet therapy, such as aspirin, thienopyridines, and/or GP IIb/IIIa inhibitors. UA and NSTEMI are the most common forms of acute coronary syndromes.
"On the strength of the ACUITY trial results, Angiomax is included in U.S. ACS guidelines for the first time," said John Kelley, President and Chief Operating Officer of The Medicines Company "The clinical importance of the ACUITY data have supported publications in three leading, peer-reviewed medical journals and recommendations for Angiomax in the management of ACS both in the U.S. and Europe."
The Medicines Company also announced it submitted a supplemental new drug application (sNDA) to the FDA for Angiomax (bivalirudin), in support of a proposed new dosage for immediate treatment of patients with acute coronary syndromes (ACS).
For more information: www.themedicinescompany.com