CHMP Recommends Expanded Use of Angiox(R) (Bivalirudin) in Europe for Patients With Acute Coronary...(orenoxaparin) plus GPI Angiox plus GPI o...),Health

Date:11/19/2007

or enoxaparin) plus GPI, Angiox plus GPI, or Angiox monotherapy. In the Angiox monotherapy group, selective use of GPI was permitted in limited circumstances and occurred in less than 10% of patients. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management, bypass surgery or PCI.

About Angiox(R)/Angiomax(R)

Angiox/Angiomax is currently approved in the European Union and the United States as well as several other territories. It is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiox has demonstrated efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in bleeding complications remain evident across the spectrum of patients undergoing interventional therapy.

In Europe, Angiox currently is indicated as an anticoagulant for patients undergoing PCI. Please see full prescribing information available at http://www.angiox.com.

In the United States, Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and with provisional GPI in patients undergoing PCI. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.

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