June 22, 2015 - The Medicines Company announced the approval of cangrelor (Kengreal) by the U.S. Food and Drug Administration (FDA) as an adjunctive therapy to percutaneous coronary intervention (PCI). The novel, intravenous antiplatelet agent is indicated 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 (GPI).
The Medicines Company expects cangrelor to be available in the United States in July.
Cangrelor is the first and only intravenous, reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI. In clinical trials, it has been shown to reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization.
The CHAMPION PHOENIX study provided the primary evidence of efficacy for the approval of cangrelor. The results of this trial - an 11,145-patient Phase III randomized, double-blind clinical trial comparing cangrelor to oral clopidogrel in patients undergoing PCI - were published in The New England Journal of Medicine. Co-principal investigators for the CHAMPION clinical program were Robert A. Harrington, M.D., professor and chair of the Department of Medicine, Stanford University Medical School, Stanford, California, and Deepak L. Bhatt, M.D., M.P.H., executive director of interventional cardiovascular programs, Brigham and Women's Hospital, Boston, and professor, Harvard Medical School.
"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, M.D., 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."
More than 700,000 PCI procedures each year in the United States require effective antithrombin and antiplatelet therapy. Cangrelor has the potential to address the unmet needs of these patients and is well-suited for contemporary U.S. practice in the cath lab.
"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," said Gregg Stone, M.D., director of cardiovascular research and education, Columbia University Medical Center, New York-Presbyterian Hospital. "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."
Cangrelor, a synthetic, small molecule, is indicated as an adjunct to 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.
The agent is contraindicated in patients with significant active bleeding and patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.
For more information: www.themedicinescompany.com