Novel Antiplatelet Agent Gets FDA Approval

The Medicines Company announced that the Food and Drug Administration (FDA) has approved Kengreal (cangrelor) as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

Kengreal is the first and only intravenous, reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI. The approval is based on data from clinical trials showing that Kengreal can reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization. In a clinical trial comparing Kengreal to clopidogrel in over 10,000 patients, Kengreal was shown to significantly reduce the occurrence of heart attack, the need for further procedures to open the artery, and stent thrombosis. While the overall occurrence of serious bleeding was low, it was more common with Kengreal compared to clopidogrel. Approximately one in every 170 Kengreal patients had a serious bleed vs. approximately one in every 275 clopidogrel patients.

“In the U.S., the vast majority of PCI procedures are done on an ad hoc basis because clinicians want to define the coronary anatomy prior to making a treatment decision,” said J. Jeffrey Marshall, MD, FACC, FSCAI, Director, Cardiac Catheterization Lab, Northeast Georgia Medical Center and Past President, Society for Cardiovascular Angiography and Interventions (SCAI). “Cangrelor provides a benefit because it allows for antiplatelet therapy to be initiated just after the decision for PCI has been made.”

Kengreal is anticipated to be available starting in July 2015.

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