Cardiome Pharma Corp. Announces Health Canada Approval Of AGGRASTAT High Dose Bolus Regimen
Published: Jul 17, 2017
NASDAQ: CRME TSX: COM
VANCOUVER, July 17, 2017 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ:CRME / TSX:COM) today announced that the Therapeutic Products Directorate (TPD) of Health Canada has approved the AGGRASTAT® (tirofiban hydrochloride) 25 mcg/kg (high) dose bolus ("HDB") regimen, as requested under the Company's supplemental New Drug Submission (sNDS). 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."
About Acute Coronary Syndromes
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 pain1. 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 20332. Approximately 70,000 acute myocardial infarctions occur each year in Canada and some 19,000 Canadians die from this condition3.
More About AGGRASTAT®
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.
About Cardiome Pharma Corp.
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. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS® (vernakalant IV), approved in Europe, Canada, and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban hydrochloride) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome. Cardiome also commercializes ESMOCARD® and ESMOCARD LYO® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner Amomed in select European markets. Cardiome has also licensed: XYDALBA (dalbavancin hydrochloride), a second generation, semi-synthetic lipoglycopeptide approved in the EU for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults for select European and Middle Eastern nations and Canada from Allergan; and TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension for Europe, the Middle East and for Canadian markets from SteadyMed Therapeutics.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
- Amsterdam EA et al. 2014 AHA/ACC guideline for the management of patients with nonST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;64:e139228.
- Datamonitor. Acute Coronary Syndrome: Epidemiology. October 2014.
- Fitchett DH et al. Assessment and Management of Acute Coronary Syndromes (ACS): A Canadian Perspective on Current Guideline-Recommended Treatment Part 1: Non-STSegment Elevation ACS Can J Cardiol 2011; 27:S387S401.
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SOURCE Cardiome Pharma Corp.