Angiomax is a direct thrombin inhibitor which prevents the formation of fibrin from fibrinogen and
the activation of coagulation factor XII. In turn, this prevents fibrin cross linking and thrombus
stabilization. It is recommended that the drug is used in conjunction with aspirin and clopidogrel (The
Medicines Company, 2013).
Angiomax’s (bivalirudin; The Medicines Company/Daiichi Sankyo) narrow label in the US has limited
its commercial potential, despite comparing favorably to heparin. The US Food and Drug
Administration has limited the use of the drug primarily to patients who are ineligible to receive
heparin. In contrast, Angiomax is used much more widely in the five major EU markets (France,
Germany, Italy, Spain, and the UK) as a result of its wider label and inclusion in the European Society
of Cardiology (ESC) guidelines for the treatment of acute coronary syndrome (ACS). Angiomax has
experienced sales erosion since generics launched in the US in July 2015. Datamonitor Healthcare
expects this erosion to continue over the upcoming years given the availability of bivalirudin generics
from both Sandoz and Hospira.
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