New Antiplatelet Drug Approved

The US Food and Drug Administration today approved the use of cangrelor (Kengreal/The Medicines Company) for adults undergoing percutaneous coronary interventions (PCI).

The US Food and Drug Administration today approved the use of cangrelor (Kengreal/The Medicines Company) for adults undergoing percutaneous coronary interventions (PCI).

The procedure is performed about 500,000 times a year, the FDA noted, based on statistics from the US Centers for Disease Control and Prevention.

The drug prevents platelets from accumulating and creating clots that can cause serious side effects. Those include heart attack and stent thrombosis.

As with most anti-clotting drugs, cangrelor carries a serious risk, that of creating severe bleeding.

In a clinical trial comparing cangrelor’s safety to that of clopidogrel, the incidence of serious bleeding was higher in patients who got cangrelor—one case in every 170 PCI patients. With clopidgrel it was one case in every 275 patients.

But the FDA decided the risk was still low enough to approve the drug.

“For patients undergoing percutaneous coronary intervention, blood clotting an casue serious problems,”said Norman Stockbridge, MD, PhD, director of the FDA”s Center for Drug Evaluation and Research’s cardiovascular and renal drug division. “The approval of Kengreal provides another treatment option for patients.”