The Medicines Company Announces FDA Approval of KENGREAL (cangrelor) as an Adjunct to Percutaneous Coronary Intervention (PCI) for Reducing Thrombotic Events

PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ:MDCO) today announced the approval of KENGREAL™ (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 P2Y₁₂ inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor (GPI).

The Medicines Company expects KENGREAL to be available in the U.S. 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 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.”

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.”

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.

Important Safety Information

KENGREAL™ is contraindicated in patients with significant active bleeding.

KENGREAL™ is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to cangrelor or any component of the product.

Drugs that inhibit platelet P2Y₁₂ function, including KENGREAL™, increase the risk of bleeding. In CHAMPION PHOENIX, bleeding events of all severities were more common with KENGREAL™ than with clopidogrel. Bleeding complications with KENGREAL™ were consistent across a variety of clinically important subgroups. Once KENGREAL™ is discontinued, there is no antiplatelet effect after an hour.

The most common adverse reaction is bleeding.

Please see full prescribing information for KENGREAL, available at https://www.kengreal.com.