European Medicines Agency's Committee for Medicinal Products for Human Use recommends marketing authorisation for idarucizumab (Praxbind), a specific reversal agent for dabigatran

 

On 24 September 2015, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Praxbind, a specific reversal agent for dabigatran, intended for use when rapid reversal of the anticoagulant effects of Pradaxa (dabigatran etexilate) is required inadult patients.

The applicant for this medicinal product is Boehringer Ingelheim International GmbH. Praxbind will be available as 2.5 g / 50 mL solution for injection/infusion. The active substance of Praxbind is idarucizumab, a specific reversal agent for dabigatran. It is a humanised monoclonal antibody fragment that binds to dabigatran and its metabolites with very high affinity and neutralises their anticoagulant effect. It is used when rapid reversal of dabigatran effect is required. The benefits with Praxbind are its ability to reverse the anticoagulant effect of dabigatran within 5 minutes of administration, that its action lasts long enough to allow clinical emergency management of patients if needed and that it does not interfere with routine treatment in case of bleeding or urgent surgery.

Mild symptoms suggestive of hypersensitivity have been reported but a causal relationship to idarucizumab could not be established.

The full indication is: “Praxbind is a specific reversal agent for dabigatran and is indicated in adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required:
• For emergency surgery/urgent procedures
• In life-threatening or uncontrolled bleeding."
It is proposed that Praxbind be restricted to hospital use only.

CHMP Summary of Opinion