Praxbind is indicated for patients treated with Pradaxa® (dabigatran etexilate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
Boehringer Ingelheim vice president of medicine, therapeutic area cardiovascular Jörg Kreuzer said: "We are very pleased to offer Praxbind®, the first specific reversal agent for a novel oral anticoagulant, now approved by the FDA.
"With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa. While we anticipate that Praxbind will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added confidence in choosing Pradaxa®."
The FDA granted Praxbind Breakthrough Therapy Designation and the application received Priority Review.5 Praxbind® was approved under an Accelerated Approval Pathway.6 The application included data from healthy volunteers as well as results from an interim analysis of the RE-VERSE AD trial (NCT 02104947).
In the studies, the reversal effects of Praxbind were evident immediately, within minutes after administration of 5 grams of Praxbind. No procoagulant effect was observed after the administration of Praxbind®.2,3,7
"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," said Dr. Charles Pollack, lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, USA.
"The availability of Praxbind now provides a unique option for reversing anticoagulation in patients taking Pradaxa."
Boehringer Ingelheim is committed to making Praxbind available as widely as possible. Praxbind is currently being assessed by different regulatory authorities, including Health Canada. Further submissions are ongoing.