FDA Advisory Panel Recommends Against Approval Of Cangrelor Reply

The FDA’s Cardiovascular and Renal Drugs Advisory Committee today recommended against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Company. In a 7-2 vote the panel first rejected an indication  for the reduction of thrombotic cardiovascular events including stent thrombosis in patients undergoing PCI.

The panel also voted unanimously to reject a second indication…

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FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor Reply

FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and should not be approved “on that fact alone.”  But two other reviewers recommend approval.

Click here to read the full post on Forbes.

 

Cangrelor During PCI May Reduce Ischemic Events Reply

In the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) trial, the intravenous platelet inhibitor cangrelor was tested for its effect on ischemic events associated with PCI. Cangrelor is a potent, fast-acting and reversible  agent. Results of the trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.

A total of 11,145 PCI patients were randomized to a bolus and infusion of cangrelor or to a loading dose of clopidogrel. A primary endpoint event — death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours — occurred in 4.7% of the cangrelor group versus 5.9% of the clopidogrel group (adjusted OR, 0.78; 95% CI, 0.66-0.93; P=0.005). The authors calculated that 84 patients would need to be treated with cangrelor instead of clopidogrel to prevent one primary endpoint event.

Note to readers: Don’t miss this fascinating post on CardioExchange in which CHAMPION PHOENIX co-chair Deepak Bhatt responds to questions raised by Rick Lange and David Hillis in their New England Journal of Medicine editorial.

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Early Results: Antiplatelet Drug Cangrelor Appears Effective For PCI Reply

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.

Click here to read the full story on Forbes.