The reviewers did not support approval for the bridge-to-surgery indication because of the lack of clinical data from the pharmacodynamic trial – the BRIDGE study – which compared cangrelor with placebo in 210 patients with ACS or who were treated with a coronary stent and were at increased risk of thrombotic events after discontinuing an oral platelet inhibitor before coronary artery bypass graft surgery. Levels of platelet inhibition associated with a low risk of thrombotic events such as stent thrombosis were maintained in 99% of those treated with cangrelor, vs. 19% of those on placebo, a statistically significant difference (JAMA 2012;307:265-74).
While panelists said the drug could be effective for this indication, they said that a clinical study was needed to determine the drug’s risk-benefit profile in this setting and that the degree of unmet need for this use was not clear.
In a statement issued by the Medicines Company after the panel meeting, Dr. Clive A. Meanwell, the chairman and chief executive officer, said "we continue to believe in the safety and efficacy of cangrelor and look forward to working with the Agency as it completes its review." The deadline for the FDA decision is April 30.
Cangrelor has not been approved in any country to date.
The FDA usually follows the recommendations of its advisory panels. Advisory panel members have been cleared of potential conflicts related to the meeting topic. Occasionally, a panelist is given a waiver, but no waivers were given at this meeting.