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Antiplatelet Drug Cangrelor (Kengreal) Wins FDA Nod
The FDA has approved cangrelor (Kengreal, The Medicines Company), an intravenous antiplatelet drug that prevents the formation of blood clots in the coronary arteries. The treatment is indicated for adults undergoing percutaneous coronary intervention (PCI).
According to the Centers for Disease Control and Prevention, PCI is performed in approximately 500,000 patients in the U.S. each year. The coronary arteries are opened by inflating a balloon at the site of the narrowing, which is usually followed by the placement of a stent to keep the artery open. By preventing platelets from accumulating, cangrelor reduces the risk of serious clotting complications related to the procedure, including heart attack and stent thrombosis.
“For patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems,” said Norman Stockbridge, MD, PhD, 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 antiplatelet drugs, bleeding, including life-threatening bleeding, is the most serious risk associated with cangrelor.
In the pivotal Champion-Phoenix trial, which compared cangrelor with clopidogrel (Plavix, Bristol-Myers Squibb) in more than 10,000 participants, cangrelor 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 cangrelor than with clopidogrel. Approximately one in every 170 cangrelor patients experienced a serious bleed compared with approximately one in every 275 clopidogrel patients.
The FDA rejected cangrelor in April 2014 after its reviewers took issue with the way the Champion-Phoenix study was conducted, and asked The Medicines Company to re-analyze its data. The Champion-Phoenix trial followed two failed studies. The company tweaked the design of the third study to differentiate heart attacks associated with its drug from those that may have resulted from the angioplasty.
Cangrelor has an edge over clopidogrel and other oral blood thinners because it takes effect rapidly and leaves the system about 1 hour after being administered, analysts said at the time. Other antiplatelet drugs keep working for 5 days or more, significantly increasing the risk of serious bleeding if a patient needs emergency or urgent follow-up procedures. Cangrelor would also benefit patients who are unable to swallow pills, analysts said.
Sources: FDA; June 22, 2015; and Reuters; April 13, 2015.