The Medicines Company's anticoagulant Kengreal cleared by FDA

The Medicines Company announced Monday that the FDA approved its anticoagulant Kengreal (cangrelor) for use as an adjunctive therapy to percutaneous coronary intervention (PCI) in adults who have not received a P2Y12 inhibitor and who are not being treated with a glycoprotein IIb/IIIa inhibitor. In April, an agency advisory panel voted 9-2 in favour of recommending approval of the injectable therapy, following an FDA staff report that had also backed clearance of the drug for the prevention of blood clots during angioplasty.

The approval was supported by data from the Phase III
CHAMPION PHOENIX study comparing Kengreal to Sanofi and Bristol-Myers Squibb's Plavix (clopidogrel) in patients undergoing PCI. Results from the study indicated that Kengreal was associated with a 22-percent lower risk of death, heart attack, repeat procedure or stent thrombosis than Plavix, as well as a 38-percent lower risk of stent thrombosis alone.

The FDA last year declined to clear the drug after agency reviewers
questioned the conduct of the trial, as well as the quality of the data analysis. However, in the latest decision, Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs at the FDA's Center for Drug Evaluation and Research, noted that "for patients undergoing percutaneous coronary intervention, blood clotting can cause serious problems. The approval of Kengreal provides another treatment option for patients."

The Medicines Company expects Kengreal to be available in the US in July. The drug was approved by regulators in Europe in March under the name Kengrexal.

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