Phase III trial of Regado's antithrombotic system placed on hold
- Phase III trials of Regado BioScience’s Revolixys Kit anticoagulant system have been placed on hold by FDA, pending results of a data review.
- The hold covers clinical enrollment and dosing in the REGULATE-PCI study, which was designed to evaluate efficacy and safety of the Revolixys kit.
- Regado had already voluntarily paused enrollment after a Data Safety Monitoring Board (DSMB) decided to review the data. The decision was not anticipated by Regado. The FDA hold is intended to formalize FDA’s involvement in this situation until everything is resolved.
The REGULATE-PCI study involved comparing Revolixys to bivalirudin in more than 13,000 patients who are undergoing percutaneous coronary intervention (PCI). Revolixys is a system that combines a factor IX inhibitor (pegnivacogin) with a drug that can reverse the anticoagulant effect (anivamersen). BioScience’s CEO, Dr. David J. Mazzo, said, “Any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based on the DSMB’s conclusions and would always be implemented in agreement with FDA.”