On Wednesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-2-1 to recommend approval of cangrelor during PCI to reduce the risk of periprocedural thrombotic events such as MI, stent thrombosis, and ischemia driven revascularization.
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The experimental antiplatelet drug cangrelor was superior to traditional clopidogrel in reducing ischemic events at 48 hours in PCI patients, according to the Medicines Company, which is developing the drug. The company today announced positive results from the phase 3 CHAMPION PHOENIX trial, a randomized, double-blind study comparing intravenous cangrelor to oral clopidogrel in PCI patients. The primary endpoint was the composite of death, MI, revascularization and stent thrombosis at 48 hours.
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