US regulators have green-lighted the use of The Medicines Company’s bloodthinner Kengreal in patients undergoing a certain heart procedure, just over a year after its rejection and request for further analysis and information.
The US Food and Drug Administration has now approved the drug’s use in adult patients undergoing percutaneous coronary intervention (PCI), a procedure to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.
PCI is performed on around 500,000 people in the US every year and, according to the FDA, by preventing platelets from accumulating Kengreal (cangrelor) reduces the risk of serious clotting complications related to the procedure, including heart attack and clotting of the stent.
Approval was based on a clinical trial comparing Kengreal (cangrelor) to Plavix (clopidogrel) in more than 10,000 participants, which showed that it significantly reduced the occurrence of heart attack, the need for further procedures to open the artery and stent thrombosis.
The overall occurrence of serious bleeding was low but more common in patients taking Kengreal, with around one in every 170 experiencing a serious bleed compared to around one in every 275 of those taking clopidogrel, the regulator noted.
“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, 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,” he added.
Kengreal is expected to be available in the US in Julyl.