Health Canada approves Cardiome Pharma's Aggrastat high dose bolus regimen

The 25 mcg/kg Aggrastat HDB regimen (25 mcg/kg over three minutes, followed by a maintenance infusion of 0.15 mcg/kg/min) will now become the recommended dose to reduce the rate of refractory ischemic conditions, new myocardial infarction and death in high-risk patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) who undergo early percutaneous coronary intervention (PCI).

Health Canada approved the Aggrastat HDB regimen based on evidence from a number of independent studies that indicated that a higher degree of platelet inhibition was beneficial for patients in need of an urgent PCI and thus at a high risk for ischemic events.  The approval was also informed by investigator-initiated clinical studies where the clinical benefit of the Aggrastat HDB regimen was demonstrated in patients with NSTE-ACS who undergo early PCI.

"The approval of the sNDS for a high dose bolus regimen of Aggrastat for this higher risk patient population is an important accomplishment as it better aligns the Canadian, United States and European labels and best reflects current clinical practice," said Kiran Bhirangi, M.D., Cardiome's Head of Medical Affairs. "We expect that the label expansion in Canada will offer physicians the opportunity to treat even more patients suffering from NSTE-ACS."

Acute Coronary Syndromes (ACS) is a term that refers to a variety of conditions consistent with acute myocardial ischemia and/or infarction that are usually due to an abrupt reduction in coronary blood flow1. The ACS spectrum includes patients with ST-elevation myocardial infarction (STEMI) and non-ST-elevation ACS (NSTE-ACS), which is comprised of non-STEMI (NSTEMI) and unstable angina. The thrombus (i.e. blood clot that forms inside a blood vessel or chamber of the heart) formation reduces blood flow in the affected coronary artery and causes ischemic chest pain.  Research from Datamonitor estimates that in 2013, >880,000 persons in the US experienced an ACS event, while in the major five EU markets, this figure was >650,0002. Furthermore, the number of ACS incidences is expected to grow nearly 40% by 2033. Approximately 70,000 acute myocardial infarctions occur each year in Canada and some 19,000 Canadians die from this condition.

Aggrastat (tirofiban hydrochloride, or HCl) is an intravenous (IV) non-peptidal antagonist of the glycoprotein (GP) IIb/IIIa receptor, an important platelet surface receptor involved in platelet aggregation.  Aggrastat, in combination with heparin and acetylsalicylic acid (ASA), is currently approved in Canada for the management of patients with unstable angina or non-Q-wave myocardial infarction, including patients who may subsequently undergo PCI to decrease the rate of refractory ischemic conditions, new myocardial infarction and death.  By blocking fibrinogen from binding to the GP IIb/IIIa receptor, Aggrastat prevents the crosslinking of platelets, which is the basis for platelet aggregation.  Aggrastat is commercialized in 60 countries worldwide, either by Cardiome or via its extensive distributor and partner network. Cardiome acquired Canadian Aggrastat commercialization rights through its acquisition of Correvio LLC in November 2013.

Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of innovative therapies that will improve the quality of life and health of patients suffering from disease.

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