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US FDA approves Medicines Company’s Kengreal as an adjunct to PCI for reducing thrombotic events
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The US Food and Drug Administration (FDA) has approved the 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).

The Medicines Company expects Kengreal to be available in the US in July.

Kengreal is the first and only intravenous, reversible P2Y12 platelet inhibitor with an immediate onset of action for patients undergoing PCI that, in clinical trials, has been shown to reduce the risk of periprocedural thrombotic events, including myocardial infarction, stent thrombosis, and repeat coronary revascularization.

“The approval of Kengreal provides a new option for PCI,” said Clive A. Meanwell, MD, PhD, chairman and chief executive officer, The Medicines Company. “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 CHAMPION PHOENIX study provided the primary evidence of efficacy for the approval of Kengreal. The results of this trial, an 11,145 patient Phase 3 randomized, double-blind clinical trial comparing Kengreal to oral clopidogrel in patients undergoing PCI, were published in The New England Journal of Medicine. Co-principal investigators for the CHAMPION clinical programme were Robert A. Harrington, MD, Professor and Chair of the Department of Medicine, Stanford University Medical School, Stanford, CA and Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programmes, Brigham and Women’s Hospital, Boston, MA and Professor, Harvard Medical School, Boston, MA.

“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, MD, 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.”

PCI, commonly known as coronary angioplasty, is a non-surgical procedure used to treat narrowed arteries found in coronary heart disease. More than 700,000 PCI procedures each year in the US require effective antithrombin and antiplatelet therapy. Kengreal has the potential to address the unmet needs of these patients and is well-suited for contemporary US 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, MD, 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.”

Kengreal, a synthetic, small molecule, is indicated as an adjunct to percutaneous coronary intervention (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.

Angiomax is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.

In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.

In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.

The Medicines Company’s purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide.

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