FDA approves Kengreal (cangrelor)as adjunctive therapy in PCI-The Medicines Company.

The Medicines Company announced the approval of Kengreal (cangrelor) by the 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 CHAMPION PHOENIX study provided the primary evidence of efficacy for the approval of Kengreal. The results of this trial, an 11,145 patient Phase II randomized, double-blind clinical trial comparing Kengreal to oral clopidogrel in patients undergoing PCI, were published in The New England Journal of Medicine.

Comment: Ad hoc PCI � in which patients with stable angina undergo angiography and PCI in the same session without being pre-treated with an oral P2Y12 inhibitor � is a common practice in the US because clinicians want to define the coronary anatomy prior to making a treatment decision. Therefore, cangrelor is a reasonable alternative to oral clopidogrel given at the start of PCI.

Comment: 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).