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Cangrelor Can’t Escape Its Past At FDA Advisory Committee

 
• By Cathy Dombrowski

The Medicines Co.’s anti-clotting drug had one relatively positive study, but two failed ones, and that produced two lopsided “no” votes by the Cardiovascular and Renal Drugs Advisory Committee.

A single Phase III study with a debatable benefit advantage did not trump two previous failed trials for The Medicines Co.’s cangrelor Feb. 12, as the Cardiovascular and Renal Drugs Advisory Committee voted 7 to 2 against approval of the anti-clotting therapy for preventing thrombotic cardiovascular events during percutaneous coronary intervention (PCI).

With a “background of two failed trials” and many issues with the third trial, “I couldn’t defend the risk-benefit advantage” for cangrelor, noted Stuart Rich, University of Chicago.

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