Centocor/Lilly’s Reopro Phase III Ischemic Stroke Study Suspended
This article was originally published in The Pink Sheet Daily
Executive Summary
Enrollment in the Abciximab in Emergent Stroke Treatment Trial-II was halted due to concerns about the rate of intracranial hemorrhage.
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Centocor and Lilly have suspended enrollment in a Phase III trial of Reopro (abciximab) for acute ischemic stroke due to concerns about the rate of intracranial hemorrhage. The trial's independent Safety & Efficacy Monitoring Committee "is in the process of evaluating the entire benefit-risk profile of Reopro for acute ischemic stroke patients before coming to a final recommendation of whether or not enrollment in the trial should resume," Lilly and the Johnson & Johnson subsidiary said in a joint statement Oct. 4. The Abciximab in Emergent Stroke Treatment Trial-II was suspended Sept. 12; 811 patients had been enrolled. "Patients currently enrolled in the trial will not receive additional study drug and data for these patients will be reviewed before the SEMC provides its recommendation on how to proceed with the AbESTT-II trial," the companies said. Data from AbESTT-II do not impact the risk-benefit profile of Reopro's approved indications, the companies maintained. The drug is approved "as an adjunct to percutaneous coronary intervention for the prevention of cardiac ischemic complications in patients undergoing PCI and in patients with unstable angina not responding to conventional medical therapy when PCI is planned within 24 hours." - Brian Marson |