The EMA has recommended granting a marketing authorization, following Accelerated Assessment, for Praxbind (idarucizumab) as a specific antidote to the anticoagulant medicine Pradaxa (dabigatran etexilate), when rapid reversal of its effect is required. Praxbind is to be used when a patient taking Pradaxa needs to undergo an emergency surgery or when life-threatening or uncontrolled bleeding occurs.
Pradaxa belongs to a new generation of oral anticoagulants (medicines that prevent the blood from clotting) approved over the past few years, which have given doctors and patients a wider range of options to prevent and treat thromboembolic disorders in adults. Praxbind is the first medicine designed to specifically neutralize the anticoagulant effect of Pradaxa.
Bleeding is a well-known complication of all anticoagulants, and information on how to address that risk has been included in Pradaxa’s product information since it was first authorized in the European Union in March 2008. Although low in frequency in patients treated with Pradaxa, major and sometimes life-threatening bleeding may occur. Unlike older oral anticoagulants such as warfarin, however, up until now there has been no specific means of rapidly neutralizing Pradaxa’s effect. Praxbind could help patients in some emergency cases where a quick reversal of the anticoagulant effect of Pradaxa is needed.
The Committee for Medicinal Products for Human Use (CHMP) decided to speed up the evaluation of the drug and recommended granting a marketing authorization following an accelerated assessment, given its potential to respond to an unmet medical need.
In clinical studies carried out in 283 healthy volunteers and 123 patients who had uncontrolled bleeding or required emergency surgery or procedures, Praxbind enabled complete reversal of Pradaxa’s anticoagulant effect within five minutes of administration with a long-lasting action allowing emergency management of patients as needed, and an overall good safety profile.
The marketing-authorization applicant for Praxbind is Boehringer Ingelheim International.