The European Commission has approved Praxbind, a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa in cases of emergency surgery or urgent procedures as well as in situations of life-threatening or uncontrolled bleeding.

Manufactured by Boehringer Ingelheim, the antidote also known as idarucizumab, is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant to be approved in the European Union.

The company’s Pradaxa is among the new generation of oral anticoagulants or medicines that prevent the blood from clotting. Bleeding is a well-known complication of all anticoagulants, but to date, there has been no specific antidote that addresses the effects of older oral anticoagulants. Praxbind seeks to help patients in some emergency situations where a quick reversal of the anticoagulant effect of Pradaxa is required.

The treatment’s approval is based on data from healthy volunteers as well as results from an interim analysis of the RE-VERSE AD clinical study. In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of five grammes of idarucizumab. It was also shown that reversal for the anticoagulant effects was complete and sustained for a minimum of 12 hours in almost all patients.

In the data submitted for approval, 123 patients from REVERSE-AD and more than 200 volunteers who were previously given idarucizumab showed no safety concerns or prothrombotic signals.

“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,” said Professor Jörg Kreuzer, vice president for medicine, therapeutic area cardiovascular at Boehringer Ingelheim.

The approval of idarucizumab by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2015.

Idarucizumab received the nod of approval from the U.S. Food and Drug Administration in October 2015.

Boehringer Ingelheim said it is committed to making idarucizumab available as widely as possible. The company will launch idarucizumab in the European Union countries as soon as national requirements allow.

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