Boehringer Ingelheim has announced that Praxbind (idarucizumab), a reversal agent for the anticoagulant Pradaxa (dabigatran etexilate mesylate), is now available in over 2,200 hospitals across the U.S. A new online locator tool was also launched to help healthcare providers and patients find institutions that stock Praxbind.
Praxbind, approved last October, was granted Breakthrough Therapy Designation by the FDA; it can reverse the anticoagulant effects of Pradaxa in case of an emergency. Specifically, Praxbind is indicated to reverse dabigatran effects in the case of urgent surgical procedures and life-threatening or uncontrolled bleeding.
The FDA approval was based on data from healthy volunteers and also an interim analysis of the RE-VERSE AD trial. In the Phase 3 study, the reversal effects of Praxbind were displayed within minutes after administration. The indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.
For more information, and to use the Praxbind locator tool, visit Praxbind.com.