FDA Approves New Antiplatelet Treatment

JUNE 22, 2015
Meghan Ross, Associate Editor
The FDA today approved The Medicines Company’s cangrelor (Kengreal), an intravenous antiplatelet medication that can prevent blood clots from forming in the coronary arteries.

Kengreal can also be used to treat adults facing percutaneous coronary intervention (PCI), a procedure that around 500,000 Americans undergo each year, according to the US Centers for Disease Control and Prevention. The treatment’s ability to prevent platelets from forming will translate to less risk for serious clotting complications associated with the procedure, including heart attacks and stent thrombosis, according to the FDA.

“For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems,” said Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research, in a press release. “The approval of Kengreal provides another treatment option for patients.”

A trial that involved more than 10,000 individuals compared Kengreal to clopidogrel (Plavix) and found that Kengreal significantly reduced the frequency of heart attacks and stent thrombosis. Those on the newly approved treatment also required fewer procedures to open the artery.

While serious bleeding was not common in the study, it did occur more often in patients taking Kengreal than Plavix. Specifically, 1 in every 170 patients taking Kengreal experienced a serious bleed, compared with 1 of 275 patients Plavix.

Kengreal carries a risk of life-threatening bleeding similar to other approved antiplatelet treatments, the FDA noted.