Cardiome Pharma (NASDAQ:CRME; TSX:COM) announced it received an approval for AGGRASTAT by Health Canada.
As quoted in the press release:
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.”
Click here to read the full press release.
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