Cardiome Pharma receives extended indications for Aggrastat in China

Canada-based Cardiome Pharma has received expanded indications from the Chinese Center for Drug Evaluation (CDE) for the use of its Aggrastat (tirofiban hydrochloride) in ST-segment elevation myocardial infarction (STEMI) patients intended for primary percutaneous coronary intervention (PCI). The agency also approved Aggrastat high-dose bolus (HDB) regimen followed by a continuous infusion of 0.15mcg/kg/min for the treatment of patients with STEMI or acute coronary syndromes without ST elevation (NSTE-ACS). Aggrastat is an intravenous (IV) non-peptidal antagonist of the glycoprotein (GP) IIb/IIIa platelet surface receptor associated with platelet aggregation. It inhibits the binding of fibrinogen to the GP IIb/IIIa receptor to prevent the cross-linking or aggregation of platelets Currently commercialised in 60 countries, Aggrastat was previously approved in China for patients with NSTE-ACS and for preventing ischemic complications due to coronary angioplasty procedures. label expansion in China is a highly positive development for the Aggrastat franchise because it significantly expands the number of patients in which the drug can be used to now include both NSTE-ACS and STEMI patients.