FDA Approves Kengreal
FDA Approves Antiplatelet Agent Kengreal (cangrelor) as Adjunct to Percutaneous Coronary Intervention
June 22, 2015 -- The U.S. Food and Drug Administration today approved Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries, the blood vessels that supply blood to the heart. It is approved for adult patients undergoing percutaneous coronary intervention (PCI), a procedure used to open a blocked or narrowed coronary artery to improve blood flow to the heart muscle.
According to the Centers for Disease Control and Prevention, PCI is performed on approximately 500,000 people in the United States each year. The coronary arteries are opened by inflating a balloon at the site of the narrowing, usually followed by placement of a small mesh tube, called a stent, to keep the artery open.
By preventing platelets from accumulating, Kengreal reduces the risk of serious clotting complications related to the procedure, including heart attack and clotting of the stent (stent thrombosis).
“For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “The approval of Kengreal provides another treatment option for patients.”
As with other FDA-approved anti-platelet drugs, bleeding, including life-threatening bleeding, is the most serious risk of Kengreal.
In a clinical trial that compared Kengreal to Plavix (clopidogrel) in more than 10,000 participants, Kengreal 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 with Kengreal than with clopidogrel. Approximately one in every 170 Kengreal patients had a serious bleed versus approximately one in every 275 clopidogrel patients.
Kengreal is manufactured by The Medicines Company based in Parsippany, New Jersey.
Posted: June 2015
- FDA Advisory Committee Recommends Approval of The Medicines Company's Antiplatelet Therapy Cangrelor - April 15, 2015
- The Medicines Company Receives Complete Response Letter From FDA for Antiplatelet Agent Cangrelor - April 30, 2014
- FDA Advisory Committee Recommends Against Antiplatelet Therapy Cangrelor - February 12, 2014
- Totality of Data From Three Phase III Trials of The Medicines Company's Intravenous Cangrelor Presented and Published - September 3, 2013
- FDA Accepts the Filing of The Medicines Company's New Drug Application for Intravenous Antiplatelet Agent Cangrelor - July 1, 2013
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