The FDA’s Cardiovascular and Renal Medicines Advisory Committee these days advised against the approval of cangrelor, the investigational new antiplatelet drug from the Medicines Firm. In a 7-2 vote the panel 1st rejected an indication for the reduction of thrombotic cardiovascular occasions such as stent thrombosis in patients undergoing PCI.
The panel also voted unanimously to reject a second indication, for the maintenance of antiplatelet therapy in patients with acute coronary syndromes or sufferers with stents who have discontinued antiplatelet therapy due to the fact they are awaiting surgical treatment and are at higher threat for thrombotic occasions. FDA reviewers, who had delivered mixed opinions for the first indication, had suggested a total response letter for the 2nd indication, because the company had failed to complete a trial showing clinical advantage for the indication.
During the day panel members wrestled with issues with the pivotal CHAMPION PHOENIX trial, which attempted to treatment the deficiencies of two earlier damaging trials. Even though most panel members agreed that PHOENIX showed a advantage compared to the clopidogrel handle group, the advantage appeared small and the committee was concerned that cangrelor may possibly have acquired an unfair advantage simply because in the handle group clopidogrel was not used ideally, given that several did not receive preloaded large-dose clopidogrel. An additional concern was that most of the difference amongst the groups was due to a reduction in periprocedural MIs. Panelists after again raised the query of the clinical relevance of this obtaining. Finally, the higher threat of bleeding with clopidogrel appeared to largely offset the observed advantages.
Panel member Milton Packer, who voted against approval, explained that he needed to vote yes and that he considered an antiplatelet agent with fast on/off properties may properly demonstrate beneficial. But, he said, the sponsor had not demonstrated that cangrelor was superior to full dose clopidogrel.
FDA Advisory Panel Recommends Towards Approval Of New Medicines Firm Heart Drug
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