The Medicines Company MDCO today announced the approval of
KENGREAL(TM) (cangrelor) by the U.S. Food and Drug Administration (FDA) as
an adjunctive therapy to percutaneous coronary intervention (PCI) for
reducing periprocedural thrombotic events in patients who have not been
treated with a P2Y(12) inhibitor and are not being given a glycoprotein
IIb/IIIa inhibitor (GPI).
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KENGREAL(TM)(cangrelor)(Photo: Business Wire)
The Medicines Company expects KENGREAL to be available in the U.S. in July.
KENGREAL is the first and only intravenous, reversible P2Y(12) 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(R), 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(TM). 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
program 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
Programs, 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 U.S. require effective antithrombin
and antiplatelet therapy. KENGREAL has the potential to address the unmet
needs of these patients and is well-suited for contemporary U.S. 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."
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