EC approves Boehringer Ingelheim’s Praxbind anticoagulant reversal agent

Idarucizumab is indicated to reverse the anticoagulant effects of dabigatran etexilate during emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding.

It binds specifically to dabigatran molecules only, neutralising their anticoagulant effect without interfering with the coagulation cascade.

The approval was based on data from healthy volunteers and results from an interim analysis of the RE-VERSE AD clinical trial.

The company said the reversal effects of idarucizumab were evident immediately following administration of 5 grams of idarucizumab. Reversal was complete and sustained for a minimum of 12 hours in almost all patients.

Boehringer Ingelheim vice president of medicine, therapeutic area cardiovascular Jörg Kreuzer said: "With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa.

"And while we anticipate that Praxbind will be rarely used in clinical practice, the availability of this specific reversal agent can now give physicians and patients added confidence in choosing Pradaxa."

Boehringer Ingelheim is undertaking regulatory reviews and submissions for idarucizumab in other countries. It is claimed to be the only specific reversal agent for a NOAC presently in regulatory review.

The company intends to submit idarucizumab in all countries where dabigatran is licensed.