The FDA approved cangrelor on June 22 for adults undergoing PCI. The intravenous medication (Kengreal, The Medicines Company) is an antiplatelet drug and is intended to prevent blood clots.
On April 15, an FDA advisory committee voted 9-2 in favor of the approval of cangrelor, 14 months after the committee had voted against the drug’s approval.
The approval was based on results of the CHAMPION PHOENIX study, which was presented at ACC.13. The phase 3 trial included 11,145 patients who were randomized to receive cangrelor or clopidogrel.
The researchers found 4.7 percent of patients in the cangrelor group and 5.9 percent of patients in the clopidogrel group achieved the primary efficacy endpoint, which was a composite of death, MI, ischemia-driven revascularization or stent thrombosis at 48 hours after randomization.
Patients who received cangrelor had a significant reduction in ischemic events, while severe bleeding occurred in one in every 170 patients in the cangrelor group and one in every 275 patients in the clopidogrel group.
In a news release, the FDA said approximately 500,000 people in the U.S. undergo PCI each year.