Boehringer Ingelheim receives European approval for Praxbind

Boehringer Ingelheim has announced that Praxbind, its specific reversal agent for its anticoagulant Pradaxa, has been approved by the European Commission.

The treatment is designed to rapidly and specifically reverse the anticoagulant effects of Pradaxa in cases of emergency surgery, urgent procedures or situations of life-threatening or uncontrolled bleeding.

It represents the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant to be approved in the EU, following on from its approval by the US Food and Drug Administration last month.

In clinical studies, the reversal effects of idarucizumab were complete and evident within minutes after administration. This effect was sustained for a minimum of 12 hours in almost all patients.

Professor Jorg Kreuzer, vice-president for medicine within Boehringer Ingelheim's cardiovascular business, said: "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."

Pradaxa has been in the market for more than seven years and is approved in over 100 countries.