Cardiome Pharma Corp., a specialty pharmaceutical company dedicated to the development and commercialisation of cardiovascular therapies, has submitted a Supplemental New Drug Submission (sNDS) to Health Canada’s Therapeutic Products Directorate for Aggrastat (tirofiban hydrochloride).
The sNDS includes data to support: 1) high dose bolus administration of Aggrastat; and 2) an indication expansion for the reduction of major cardiovascular events in patients with acute myocardial infarction (STEMI) intended for primary PCI.
“We are excited to submit an sNDS to Health Canada that includes the high dose bolus administration and STEMI primary PCI label indication”, said William Hunter, M.D., chief executive officer and director of Cardiome.
“While Aggrastat is already approved in Canada, the addition of these two protocols would better align Aggrastat’s Canadian label with its label in Europe, and will more accurately reflect the most recent evidence and actual clinical use, while making the drug more competitive within the Canadian market. If provided, we expect that the label expansion would grow the market for Aggrastat in Canada as these additions provide more support for using the drug to treat major cardiovascular events in patients. Furthermore, the action that we have taken by submitting this sNDS is one of the first steps in building our Canadian product portfolio. We expect to file additional NDS’ within the foreseeable future, including one for BRINAVESS in the coming months. ”
Aggrastat, in combination with heparin and ASA is currently indicated in Canada for the management of patients with unstable angina or non-Q-wave myocardial infarction, including patients who may subsequently undergo PTCA (percutaneous transluminal coronary angioplasty), to decrease the rate of refractory ischemic conditions, new myocardial infarction and death.
Aggrastat is a reversible non-peptide antagonist of fibrinogen binding to the GP IIb/IIIa receptor, the major platelet surface receptor involved in platelet aggregation. When administered intravenously, tirofiban inhibits ex vivo platelet aggregation in a dose and concentration dependent manner. Cardiome acquired Canadian Aggrastat commercialisation rights through its acquisition of Correvio LLC in November 2013.