Boehringer Ingelheim has received approval from the European Commission for Praxbind (idarucizumab), a treatment designed to quickly reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery or in situations of uncontrolled bleeding.
Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to receive European approval.
Approval follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use for idarucizumab in September.
In October, idarucizumab secured approval from the US Food and Drug Administration (FDA).
The European approval is based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD clinical trial.
In the data submitted for approval, including 123 patients from REVERSE-AD and more than 200 volunteers previously given idarucizumab, no safety concerns or prothrombotic signals were observed.
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Vivantes Neukoelln Medical Centre Department of Cardiology, Vascular Medicine, Nephrology and Intensive Care Medicine director and clinical study lead investigator Harald Darius said: "Anticoagulants offer important benefits to patients at risk of thromboembolic events. However, even though rare, there will be situations when reversal of anticoagulation is medically necessary.
"The approval of Praxbind now provides me and my colleagues with an important option to manage patients taking Pradaxa in situations when speed of reversal matters."
The company noted that in the trials, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5gm of idarucizumab, while reversal was complete and sustained for a minimum of 12 hours in almost all patients.
Boehringer Therapeutic Area Cardiovascular vice-president medicine 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."
Image: Boehringer Ingelheim Center (BIC), the corporate headquarters building in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.