FDA Approves Boehringer Ingelheim's Praxbind Reversal Agent for Pradaxa

October 19, 2015—Boehringer Ingelheim Pharmaceuticals, Inc. recently announced that the US Food and Drug Administration (FDA) granted approval of Praxbind (idarucizumab), which is indicated for patients treated with the company’s Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. The company advised that continued approval for this indication may be contingent upon the results of an ongoing cohort case series study, and that Praxbind will be available from major hospital pharmacy distributors in the United States as soon as possible.

According to Boehringer Ingelheim Pharmaceuticals, the FDA granted breakthrough therapy designation for Praxbind and the application received priority review. Praxbind was approved by the FDA under an accelerated approval pathway. The application included data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD trial. In the studies, the reversal effects were evident within minutes after administration of 5 grams of Praxbind, and no procoagulant effect was observed after the administration of Praxbind.

In the company’s press release, RE-VERSE AD lead investigator Charles Pollack, MD, commented, “The emergence of novel oral anticoagulants, or NOACs, marked a significant advancement in anticoagulation care. While general management strategies for NOAC-related bleeding are available, until today, there was no option for specific and immediate reversal of the anticoagulant effect of a NOAC in a patient in rare emergencies where speed matters, such as life-threatening bleeding or the need to quickly perform surgery or interventions. The availability of Praxbind now provides a unique option for reversing anticoagulation in patients taking Pradaxa.” Dr. Pollack is Professor of Emergency Medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, in Philadelphia, Pennsylvania.