Praxbind® (idarucizumab) licensed in European Union for the specific reversal of Pradaxa® (dabigatran etexilate)

  1. Idarucizumab is the first specific reversal agent for a NOAC to receive European licence1
  2. Idarucizumab immediately reverses the anticoagulant effect of dabigatran2-4

Bracknell, United Kingdom - 26th November 2015 – The European Commission has licensed Praxbind® (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of Pradaxa® (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding.1 Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) to be granted a licence in the European Union.1

 

Dr Steve Austin, Lead investigator for REVERSE- AD trial in the UK said 

“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.”

The licensing of idarucizumab by the European Commission follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2015.5 Idarucizumab was already licensed by the U.S. Food and Drug Administration in October 2015.6

 

The licence is based on data from healthy volunteers, as well as results from an interim analysis of the RE-VERSE AD™ clinical study.2-4,7 In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab.2-4 Reversal was complete and sustained for at least 12 hours in almost all patients.2-4 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.2-4,7,8

References

  1. Praxbind® Summary of Product Characteristics, Boehringer Ingelheim, 2015.
  2. Pollack C. V., et al. Idarucizumab for Dabigatran Reversal. NEJM. 2015;373:511-520.
  3. Glund S, et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015;386:680–690.
  4. Glund S. et al. Idarucizumab, a Specific Antidote for Dabigatran: Immediate, Complete and Sustained Reversal of Dabigatran Induced Anticoagulation in Elderly and Renally Impaired Subjects. Oral presentation on 8 December 2014 at The 56th American Society of Hematology Annual Meeting & Exposition, San Francisco, USA. 2014;124:Abstract 344.