Cardiome Pharma has announced that the Therapeutic Products Directorate of Health Canada has approved the tirofiban (Aggrastat) 25mcg/kg high-dose bolus regimen, as requested under the company’s supplemental new drug submission.
A press release reports that the 25mcg/kg high-dose bolus regimen (25mcg/kg over three minutes, followed by a maintenance infusion of 0.15mcg/kg/min) will now become the recommended dose to reduce the rate of refractory ischaemic conditions, new myocardial infarction and death in high-risk patients with non-ST-elevation acute coronary syndrome (NSTE-ACE) who undergo early percutaneous coronary intervention (PCI).
Health Canada approved the new high-dose regimen, according to the press release, 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 ischaemic events. The approval was also informed by investigator-initiated clinical studies where the clinical benefit of the tirofiban high-dose bolus regimen was demonstrated in patients with NSTE-ACS who undergo early PCI.
Kiran Bhirangi, Cardiome’s Head of Medical Affairs, says: “The approval of the supplemental new drug submission for a high -dose bolus regimen of Aggrastat for this higher risk patient population is an important accomplishment as it better aligns the Canadian, USA and European labels and best reflects current clinical practice. We expect that the label expansion in Canada will offer physicians the opportunity to treat even more patients suffering from NSTE-ACS.”