The Medicines Company's Kengreal Approved as an Adjunct to PCI

June 22, 2015—The Medicines Company announced US Food and Drug Administration (FDA) approval of Kengreal (cangrelor) as an adjunctive therapy to percutaneous coronary intervention (PCI) for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. European approval of cangrelor under the trade name Kengrexal was announced in March. Kengreal is expected to be available in the United States in July, advised the company.

According to The Medicines Company, intravenous Kengreal is a reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI that, in clinical trials, has been shown to reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization. 

The primary evidence for the FDA approval of Kengreal was provided by the CHAMPION PHOENIX study. This 11,145-patient, phase-3, randomized, double-blind clinical trial compared Kengreal to oral clopidogrel in patients undergoing PCI. The CHAMPION PHOENIX results were reported by Deepak L. Bhatt, MD, in March 2013 at the American College of Cardiology’s 62nd annual scientific session and were published concurrently in The New England Journal of Medicine (2013;368:1303–1313). Data from the CHAMPION pooled population of more than 25,000 PCI patients provide additional clinical support regarding safety.

In The Medicines Company press release, J. Jeffrey Marshall, MD, commented, “In the US, 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. Cangrelor provides a benefit because it allows for antiplatelet therapy to be initiated just after the decision for PCI has been made.” Dr. Marshal is Director of the Cardiac Catheterization Lab at Northeast Georgia Medical Center in Gainesville, Georgia, and is Past President of the Society for Cardiovascular Angiography and Interventions.

Gregg Stone, MD, added, “I believe that intravenous cangrelor has the potential to substantially improve outcomes for patients with cardiovascular disease because of its immediate onset of near complete platelet inhibition with rapid reversibility. With decreasing door-to-procedure times and the limitations of all oral anti platelet agents, I believe cangrelor will be widely embraced by the interventional community.” Dr. Stone is Director of Cardiovascular Research and Education at Columbia University Medical Center, New York-Presbyterian Hospital in New York, New York.