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news.After reviewing a benefit-risk profile, Centocor and Eli Lilly have decided not to resume their phase III trial of Reopro for the treatment of acute ischemic stroke. As previously reported, the trial was suspended in early October amid safety concerns.
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Based on careful review of the data and the observed benefit-risk profile, the trial’s independent Safety and Efficacy Monitoring Committee (SEMC) recommended that the study not resume enrollment. After reviewing these recommendations, the principal investigators unanimously agreed with the SEMC and have permanently discontinued enrollment in the trial.
“Patient safety is paramount to all of our drug development programs, so we have taken the prudent step of ending the AbESTT-II trial,” said Dr Jerome Boscia, senior vice president, clinical R&D, Centocor. “While there are no guarantees that every clinical study will succeed, Centocor and Lilly maintain their R&D commitments to researching and developing safe, effective therapies for patients in need.”
Reopro is currently approved in the US and many other countries around the world as an adjunct to percutaneous coronary intervention (PCI) 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. Safety concerns from the acute ischemic stroke trial do not reflect upon the already approved indication for the drug.