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. … Click here to read the full post on Forbes. …
FDA Advisory Panel Recommends Against Approval Of Cangrelor
February 12, 2014 by Leave a Comment
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… … Click…
FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor
February 10, 2014 by Leave a Comment
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…
Cangrelor During PCI May Reduce Ischemic Events
March 10, 2013 by Leave a Comment
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…
Early Results: Antiplatelet Drug Cangrelor Appears Effective For PCI
January 8, 2013 by Leave a Comment
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…
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