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news.The Medicines Company has submitted a supplemental new drug application to the FDA for Angiomax in support of a proposed new dosage for immediate treatment of patients with acute coronary syndromes.
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Angiomax is currently approved for patients undergoing percutaneous coronary intervention, commonly referred to as angioplasty.
The Medicines Company also noted that new guidelines released by the American College of Cardiology and the American Heart Association 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.
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 (ACS).
An application for marketing authorization is currently under review with European regulatory authorities to expand the approved uses of Angiox to include the emergency use of Angiox in ACS patients undergoing percutaneous coronary intervention. Angiox is the name under which Angiomax is marketed in Europe.