CHMP "thumbs up" for Angiox extension

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended extending the anticoagulent Angiox' (bivalirudin) indication to include adult acute coronary syndrome patients for whom urgent or early intervention is planned. Specifically, the CHMP has advised that the drug should be cleared to treat ACS sufferers with unstable angina or non-ST segment elevation myocardial infarction.

Angiomax was originally developed by New Jersey, USA-based The Medicines Company and has been used in the treatment of ACS patients undergoing percutaneous coronary interventions since it first gained US approval in December 2000 (Marketletters passim). Having recently re-acquired full European rights to the drug from Denmark's Nycomed (Marketletter July 9), TMC said it has been actively expanding its European presence, and has worked with leaders in cardiology, thrombosis and health economics to develop its plans for the drug.

John Kelley, TMC's president, said: "the CHMP recommendation will accelerate our efforts to establish Angiox as the preferred anti-thrombotic strategy for patients who require PCI for coronary artery disease in Europe." He added that the company expects to receive a final EMEA approval decision in the first quarter next year, which will coincide with its expansion of commercial operations in the region.