Pharma Focus Asia

Cardiome Announces Expanded Label For Aggrastat® In China Including New Stemi Indication And High Dose Bolus Regimen

Wednesday, January 24, 2018

Cardiome Pharma Corp., a revenue-generating, specialty pharmaceutical company focused on commercializing patent-protected hospital drugs, today announced that the Chinese Center for Drug Evaluation (CDE) has approved an expansion of the indications for Aggrastat (tirofiban hydrochloride) to now, 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). In addition to the expanded indications, the CDE also approved an Aggrastat high dose bolus (HDB) regimen (25 mcg/kg over a 3-minute period, followed by continuous infusion of 0.15 mcg/kg/min for 12-24 hours and up to 48 hours) to be used on both indicated patient populations.

“This label expansion in China is a highly positive development for the Aggrastat franchise because it significantly expands the number of patients in which the drug can be used to now include both NSTE-ACS and STEMI patients,” commented Kiran Bhirangi, M.D., Cardiome’s Vice President, Clinical Development and Medical Affairs. “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.”

In China, Aggrastat was previously indicated for use in patients with NSTE-ACS, as well as to prevent ischemic complications as a result of coronary angioplasty procedures. The new expanded label will include both STEMI and NSTE-ACS. Aggrastat is currently marketed by Cardiome in over 60 countries worldwide.

The Aggrastat HDB regimen will now become the recommended dose regimen to reduce the rate of refractory ischemic conditions, new myocardial infarction and death in both STEMI patients set to undergo PCI and NSTE-ACS patients who undergo early PCI. The CDE’s approval of the Aggrastat label expansion is based on results from several clinical trials demonstrating the tolerability, and risk reduction of myocardial infarction and death by Aggrastat when compared to placebo and other agents. These studies 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, and that clinical benefit of the Aggrastat HDB was demonstrated in patients with NSTE-ACS who undergo early PCI, as well as in STEMI patients undergoing primary PCI. Cardiome’s partner, Eddingpharm, markets and distributes Aggrastat in China and executes regulatory initiatives such as this label expansion.

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