25 September 2015 - The European Medicines Agency (EMA) has recommended granting a marketing authorisation, 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 neutralise the anticoagulant effect of Pradaxa.

Bleeding is a well-known complication of all anticoagulants, and information on how to address this risk has been included in Pradaxa's product information since it was first authorised in the European Union (EU) in March 2008. Although low in frequency in patients treated with Pradaxa, major and sometimes life-threatening bleeding may occur. However, unlike older oral anticoagulants such as warfarin, up until now there has been no specific means of rapidly neutralising 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 this medicine and recommended granting a marketing authorisation following an accelerated assessment, given its potential to respond to an unmet medical need.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/09/news_detail_002399.jsp&mid=WC0b01ac058004d5c1