Boehringer Ingelheim Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Praxbind (idarucizumab) as a specific reversal agent for Pradaxa (dabigatran etexilate mesylate).
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The drug is indicated for patients treated with Pradaxa, when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery / urgent procedures or in life-threatening or uncontrolled bleeding.
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The indication is under accelerated approval based on a reduction in unbound dabigatran and normalisation of coagulation parameters in healthy volunteers.
The company said that continued approval for this indication may be based upon the results of an ongoing cohort case series study.
Praxbind has also secured FDA breakthrough therapy designation under an accelerated approval pathway.
In addition, the FDA has also granted priority review for the application, which included data from healthy volunteers and results from an interim analysis of the RE-VERSE AD trial (NCT02104947).
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By GlobalDataIn the trials, the reversal effects of Praxbind were evident immediately, within minutes after administration of 5gm of Praxbind.
The company said that no procoagulant effects were observed after the administration of Praxbind.
Sidney Kimmel Medical College Emergency medicine professor and lead investigator of RE-VERSE AD Dr Charles Pollack said: "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."
The company intends to make Praxbind available from major US hospital pharmacy distributors.
