Cangrelor Advisory Cmte. Unsure Whether Plavix Even Needs Replacing
After a brutal panel review, The Medicines Co.’s best chance for its anti-clotting medication may be to create a “better sense of the unmet need” in the perioperative setting when Plavix use must be suspended.
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FDA panel members were not enthusiastic about the antiplatelet, but felt it could help ‘some people.’
Company believes it has addressed all of FDA’s concerns in an April 2014 “complete response” letter relative to use during percutaneous coronary intervention, the only indication that will be the focus of a second advisory committee review.
Agency requests additional analyses, but not a new study, supporting the antiplatelet’s use in patients undergoing percutaneous coronary intervention, The Medicines Co. says. However, a second indication in stent thrombosis patients who must stop oral antiplatelet therapy would require a new outcomes trial.