Angiox, market authorization renewal from the European Medicines Agency and the European Commission


The European Medicines Agency ( EMA ), the Committee for Medicinal Products for Human Use ( CHMP ), and the European Commission ( EC ) have granted market authorization renewal for Angiox ( Bivalirudin ) following a review of the latest clinical, safety, and efficacy data, as well as the Angiox risk management plan.
The CHMP recommendation for the renewal of the marketing authorization for Angiox reconfirms its favorable risk-benefit profile.

Angiox is a direct thrombin inhibitor and is indicated in Europe as an anticoagulant in adult patients undergoing percutaneous coronary intervention ( PCI ), including patients with ST-segment elevation myocardial infarction ( STEMI ) undergoing primary PCI.
Angiox is also indicated in Europe for the treatment of adult patients with unstable angina / non-ST segment elevation myocardial infarction ( UA/NSTEMI ) planned for urgent or early intervention.

The renewal is applicable to Angiox in all Member States of the European Union/European Economic Area. Angiox has a favorable class 1B recommendation for use in STEMI and NSTEMI patients undergoing primary PCI in the European Society of Cardiology guidelines.

In more than 20 years of clinical study, Bivalirudin has been shown to provide comparable efficacy and reduced bleeding versus Heparin with or without glycoprotein IIb/IIIa inhibitor ( GPI ) use in patients undergoing PCI.
Bivalirudin has been studied in thirteen multi-Center clinical trials and one-single Center randomized clinical trial in more than 35,000 patients, supporting the use of Bivalirudin in the PCI setting regardless of femoral or radial access site and type of P2Y12 inhibitor.
In STEMI patients, Bivalirudin has demonstrated the reduction of mortality out to three years, independent of bleeding status.
In addition, large, observational, real-world registries have collected data from approximately 500,000 patients that also support these findings.

In the United States, Bivalirudin is marketed under the trade name Angiomax and is indicated in patients undergoing PCI with provisional use of glycoprotein IIb/IIIa inhibitor and in patients with, or at risk of, Heparin-induced thrombocytopenia and thrombosis syndrome ( HIT/HITTS ) undergoing PCI.
In addition, Angiomax is also indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty ( PTCA ).
Angiomax is intended for use with Aspirin.
Angiomax is not approved for use in patients with acute coronary syndromes ( ACS ) not undergoing PCI or PTCA.

In clinical trials comparing Angiomax and Heparin, the most common adverse reaction for Angiomax was bleeding ( 28% ). Other common adverse reactions were headache, thrombocytopenia and fever.
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 should be used with caution in patients with disease states associated with an increased risk of bleeding. In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax.
Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. ( Xagena )

Source: The Medicines Company, 2014

XagenaMedicine_2014



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