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The Food and Drug Administration has rejected the approval of the intravenous antiplatelet drug cangrelor, suggesting that the company provide more data, according to the drug’s manufacturer.
The Medicines Company applied for approval of cangrelor for two indications: the reduction of death, MI, stent thrombosis, and ischemic-driven revascularization in patients who have not been recently treated with a thienopyridine and who are undergoing PCI; and for patients with stents who are at an increased risk for thrombotic events, such as stent thrombosis, when oral P2Y12 therapy is interrupted for surgery.
At a meeting earlier this year, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 7-2 against approval of the first indication, and unanimously voted against approval of the second indication, citing numerous issues with clinical trials.
The company’s April 30 statement announcing the FDA decision said that the agency had suggested that the company conduct "a series of data analyses" from the CHAMPION PHOENIX study that was the basis of the PCI indication (N. Engl. J. Med. 2013;368:1303-13).
The FDA also concluded that a prospective controlled study to evaluate the risk-benefit of cangrelor for the second bridging indication with outcomes that included bleeding was needed, the statement said. For this indication, the company had submitted only a small pharmacodynamic study, which showed that a cangrelor infusion could maintain platelet inhibition similar to that achieved with clopidogrel.
In the statement Dr. Clive A. Meanwell, the company’s chairman and chief executive officer, said that "the next steps of review will focus on additional analyses in response to the FDA."
Cangrelor is a platelet P2Y12 inhibitor administered intravenously; with a half-life of 3-6 minutes, platelet function returns to normal within 1 hour of stopping the infusion of cangrelor, according to the company. The oral P2Y12 inhibitor clopidogrel has a more delayed action, with activity that lasts for days after is stopped.