Cangrelor’s Approval Prospects: FDA Reviewers Say Yes, Team Leader Says No
This article was originally published in The Pink Sheet Daily
As The Medicines Co.’s anticlotting drug heads to the Cardiovascular and Renal Drugs Advisory Committee, questions about comparator dosing and timing and the severity of bleeding events will be on the agenda.
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FDA reviewers again recommended approval of the antiplatelet, but this time there doesn’t appear to be opposition from the team leader.
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.
The Medicines Company seemed positive about the prospects for approval of its anti-clotting drug, even though an advisory committee voted against approval just a week ago.