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Medicines licensing

Cangrelor approved for use in the United States

Cangrelor has been approved for use in adult patients undergoing percutaneous coronary intervention (PCI) in the United States, following a decision by the US Food and Drug Administration (FDA).

The drug, known as Kengreal in the United States and as Kengrexal in Europe, is an intravenous antiplatelet agent that prevents clots forming and reduces the risk of serious clotting complications – including heart attack and stent thrombosis – in this group of patients.

The decision by the FDA will provide a new treatment option for the estimated 500,000 patients in the United States who undergo PCI every year.

The FDA considered data from a clinical trial of 10,000 patients, in which the drug reduced the occurrence of heart attack or the need for further coronary procedures when compared with another antiplatelet medicine clopidogrel (Plavix). The trial also showed that one in every 170 patients given cangrelor had a serous bleed compared with one in every 275 clopidogrel patients.

The FDA decision comes three months after cangrelor was given marketing authorisation across the EU for the treatment of patients with acute coronary syndrome and vascular surgical procedures.

The European Medicines Agency concluded that cangrelor’s benefits outweighed its risks: “Although the incidence of bleeding was higher for Kengrexal than for clopidogrel, this was expected given the greater effectiveness of the medicine, and was offset by the fact that the activity of Kengrexal wore off quickly once the infusion was stopped.” 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068822

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