CDE assents expansion of AGGRASTAT for CARDIOME

Chinese Center for Drug Evaluation has sanctioned an expansion of  expansion of the indications for Aggrastat for pharmaceutical company focused on commercializing patent-protected hospital drugs, Cardiome Pharma Corporation in addition to acute coronary syndromes without ST elevation (NSTEACS) include patients with ST-segment elevation myocardial infarction (STEMI), who are intended for primary percutaneous coronary intervention (PCI).

Kiran Bhirangi, M.D., Cardiome’s Vice President, Clinical Development and Medical Affairs said “Identifying STEMI patients is done via a standard 12-lead ECG, so is therefore a fast, easy and cost-effective means to capturing these additional high-risk patients who stand to benefit from treatment with Aggrastat. The inclusion of
the HDB regimen is also important because it aligns the Chinese posology with that used in the U.S., Europe and Canada and better reflects current clinical practice.”

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 coronaryblood flow. 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.