ACC 2016: Boehringer's Pradaxa 'antidote' passes real-world test
- Boehringer Ingelheim's anticoagulant reversal agent Praxbind proved effective in stopping bleeding episodes in real-world emergency situations, new interim phase 3 data showed.
- Praxbind (idarucizumab) is the reversal agent for the blood thinner Pradaxa (dabigatran), and has been highlighted in Boehringer's new marketing push for Pradaxa. Approved in October, 2015 after roughly six years of development, Praxbind is designed to address Pradaxa-related adverse events.
- Patients needed anticoagulation reversal for one of two reasons: in order to undergo urgent surgery or because they had spontaneously developed a life-threatening bleed. Treatment with Praxbind reversed the blood-thinning effects of Pradaxa in all accessible patients.
The FDA approved Praxbind under an accelerated approval program with the condition additional safety and efficacy data would be forthcoming. Its approval followed a five-year period during which 1,400 Pradaxa-related adverse events (AEs)—mainly extended bleeding episodes—were reported. There were also 280 reported deaths related to use of Pradaxa.
The trial, called RE-VERSE AD, was designed to evaluate how effective Praxbind is when Pradaxa-treated patients face emergency situations, such as a traumatic car accident, emergency surgery, or intracranial hemorrhage. The study began in May 2014 and enrolled up to 500 patients from 35 countries.
Among the 123 patients in this analysis, 66 had uncontrolled bleeding complications and 57 required emergency surgery. Reversal was evident in all of the patients who were assessed.
Some side effects did crop up. Thrombotic events occurred in five patients between two to 24 days after they received Praxbind. However, none of these patients were receiving antithrombotic therapy at the time of their event. There were 26 deaths overall, which appeared to be tied to the original reason for emergency admission.
“The data from this new RE-VERSE AD interim analysis, of the first 123 patients, support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care,” said Dr. Charles Pollack, the lead trial investigator.
The latest interim analysis of the ongoing study is important not only for regulatory purposes, but also for payers, who are most interested in the real-world effect of medications.
- Boehringer Ingelheim Press Release