Regado Biosciences has announced that, further to their decision to voluntarily pause enrolment in their REGULATE-PCI trial, the United States Food and Drug Administration (FDA) informed the company that a clinical hold has been placed on all patient enrolment and dosing of either study drug in the ongoing phase 3 REGULATE-PCI trial. According to the FDA, this action was taken to formalise the involvement of the FDA in any decision to re-initiate enrolment and dosing in the trial in the future.
“As announced earlier, we remain blinded to REGULATE-PCI study data and are awaiting the outcome of the full safety and efficacy analysis, including an analysis of benefit/risk ratio, being performed by our Data and Safety Monitoring Board (DSMB). Any recommendation to re-initiate patient enrolment in REGULATE-PCI will be based on the DSMB’s conclusions and would always be implemented in agreement with FDA,” states Regado chief executive officer, David J Mazzo.
