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Boehringer’s Praxbind reversal agent wins EU approval

Published on 26/11/15 at 03:24pm

The European Commission has approved Boehringer Ingelheim’s Praxbind (idarucizumab)- a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa (dabigatran etexilate) in cases of emergency surgery or in situations of life-threatening or uncontrolled bleeding.

The European green light follows Praxbind’s approval in the US in October as well as the CHMP (EMA) nod in September, and makes it the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be granted a licence in the European Union.

The Commission granted the license based on data from healthy volunteers, as well as the results from an interim analysis of the RE-VERSE AD clinical study, in which the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab.

Reversal was complete and sustained for at least 12 hours in almost all patients. In the data submitted for authorisation, including 123 patients from RE-VERSE AD and more than 200 volunteers previously given idarucizumab, no safety concerns or prothrombotic signals were observed.

Boehringer’s Pradaxa (dabigatran) was in 2010 the first in a new class of anticoagulants to be approved- offering comparable blood-thinning effects to warfarin without the need for ongoing monitoring.

However, safety concerns over the risk of severe bleeding dogged this class of drugs, and Boehringer believed the creation and approval of an effective antidote would alleviate concerns and give it an edge over its rivals in the market. The additional approval of Praxbind, which in turn is the first specific reversal agent for a novel oral anticoagulant, is therefore welcome news to the German company.

Dr Steve Austin, lead investigator for REVERSE- AD trial in the UK, comments: “Anticoagulants offer important benefits to patients. But there are going to be very rare circumstances when rapid reversal is beneficial.

“Quickly and effectively being able to reverse the anticoagulant effect is therefore a critical consideration for doctors. It has been very pleasing to see the positive effect of idarucizumab use in the UK and Ireland during the REVERSE- AD trial, and I’m delighted this data, when added to that of the overall study, has made the authorisation of idarucizumab possible.

“It provides myself and my colleagues with further reassurance for safe anticoagulant care for patients here in the UK and Ireland.”

Boehringer Ingelheim said it would commit to making idarucizumab as widely available as possible, and that it will launch the product in European Union countries as soon as national requirements allow.

Joel Levy

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