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news.The US Food and Drug Administration (FDA) has approved Medicines Company's 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 (GPI).
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The new intravenous antiplatelet agent adds to the company’s commercial offerings in the cardiac cath lab.
The company intends to introduce kengreal, which is the first and only intravenous, reversible P2Y12 platelet inhibitor, in the US this July.
In clinical trials, kengreal was found to reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization.
The Medicines Company chairman and chief executive officer Clive Meanwell said: "The approval of kengreal provides a new option for PCI.
"This novel drug will potentially decrease thrombotic risk in the acute care setting, deliver value to the healthcare system alongside Angiomax, and help us to increase our commercial offerings in the cath lab."
The approval was based on the Champion Phoenix study which provided the primary evidence of efficacy for kengreal.
A total of 11,145 patients were included in the randomized, double-blind clinical Phase III trial, which compared kengreal to oral clopidogrel in patients undergoing PCI.
Columbia University Medical Center Cardiovascular Research and Education director Gregg Stone said: "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."
Image: Kengreal (cangrelor) will be made available in the US this July. Photo: courtesy of Business Wire.