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The European Medicines Agency (EMEA) is recommending Angiox (bivalirudin) for adult patients with acute coronary syndromes (ACS).
The EMEA’s Committee for Medicinal Products for Human Use (CHMP) said it can specifically help people with unstable angina (UA) or non-ST segment elevation myocardial infarction (NSTEMI).
Angiox is an anticoagulant treatment currently approved in Europe for use in patients undergoing angioplasty.
John Kelley, president and chief operating officer from manufacturer The Medicines Company, said: “The CHMP recommendation will accelerate our efforts to establish Angiox as the preferred antithrombotic strategy for patients who require PCI for coronary artery disease in Europe.
“We believe the European Commission will approve expanded use of Angiox in ACS patients during the first quarter of 2008, which coincides with the expansion of our commercial operations into major European markets.”
The Medicines Company re-acquired rights to Angiox in Europe in July and has since been expanding its European operations and developing clinical and commercial plans for the drug.
The company has also been working on clinical trials for the phase III development compounds, cangrelor and Cleviprex (clevidipine butyrate injectable emulsion).
It is establishing supply chain capabilities in Europe, and has set up a central office in Zurich, Switzerland.
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