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Published on 31 January 2008

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EC authorises expanded use for bivalirubin

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The EC has authorised an expanded use for Angiox® (bivalirudin) in adult patients with acute coronary syndromes (ACS), specifically patients with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI) planned for urgent or early intervention, when used with aspirin and clopidogrel.

“With this new indication, Angiox can be used in patients experiencing ACS throughout the treatment paradigm, from arrival in the emergency department to the cardiac catheterisation laboratory,” said Dr Walter Desmet, of University Hospital Gasthuisberg, Leuven, Belgium.

“Angiox is a simple and effective option to meet the needs of ACS patients who require urgent or early.”

The approval is based on results from the ACUITY trial of 13,819 patients with ACS.

ACUITY demonstrated that Angiox with or without a glycoprotein IIb/IIIa inhibitor (GPI) resulted in similar rates of ischaemic clinical outcomes compared to standard therapy of heparin (unfractionated or enoxaparin) plus a GPI.

Angiox monotherapy was associated with 47% less major bleeding compared to standard therapy.

Of the patients enrolled in ACUITY, 35% were treated at European hospitals.

The Medicines Company



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