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.
Cardiome Pharma Clinical Development and Medical Affairs vice-president Kiran Bhirangi said: “This 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.
“The inclusion of the HDB regimen is also important because it aligns the Chinese posology with that used in the US, Europe and Canada and better reflects current clinical practice.”
The approval of label expansion is based on the results from various clinical trials that validated the tolerability, as well as risk reduction of myocardial infarction and death with Aggrastat, when compared to placebo and other agents.