Boehringer Ingelheim has reported positive updated results from its ongoing Phase III RE-VERSE AD study of Praxbind (idarucizumab) to treat patients in emergency settings.
Praxbind is a humanised antibody fragment designed as a specific reversal agent to dabigatran.
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It binds specifically to dabigatran molecules and neutralise their anticoagulant effect without interfering with the coagulation cascade.
The Phase III RE-VERSE AD study enrolled 494 patients who were administered with dabigatran and had uncontrolled or life-threatening bleeding or needed emergency surgery or an invasive procedure.
Results suggested that praxbind met its primary endpoint of completely reversing the anti-coagulant effect of dabigatran within four hours as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT).
The reversal was noted immediately after Praxbind was administered.
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By GlobalDataSidney Kimmel Medical College at Thomas Jefferson University professor of emergency medicine and lead investigator of RE-VERSE AD Dr Charles Pollack said: “The availability of idarucizumab as a reversal agent for dabigatran is an important development in anticoagulation care, and RE-VERSE AD is the most robust examination of its real-world use and impact.
“These results further support that, although idarucizumab is likely to be rarely used in light of the safety profile of dabigatran, a specific reversal agent provides an important therapeutic option for physicians and patients.”
