Boehringer Ingelheim launches RE-VECTO global program to capture data on Praxbind® usage in clinical practice

  • Praxbind® (idarucizumab) is the specific reversal agent for the oral anticoagulant Pradaxa® (dabigatran)1,2
  • Praxbind® is already available in over 5,000 hospitals worldwide and is approved in over 35 countries3
  • RE-VECTO will provide insights into the diverse types of situations in which reversal of an anticoagulant is performed in clinical practice

 

Ingelheim, Germany, August 15, 2016 – Boehringer Ingelheim today announces its global RE-VECTO program for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate).1,2 Praxbind® is approved to reverse the anticoagulant effects of Pradaxa® in rare critical care situations such as prior to emergency surgery or an urgent intervention, or in cases of life-threatening or uncontrolled bleeding.1,2 The emergency situations in which Praxbind® may be used can vary greatly, ranging from a severe car accident to a ruptured appendix. Data captured in RE-VECTO will help better understand the actual usage of the reversal agent in the clinical practice setting.4 

Prof. Kreuzer
Prof. Jörg Kreuzer

“Praxbind® received its first approval in the US nearly a year ago and is now widely available in the US, the EU and several other countries worldwide,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “By their nature, every emergency situation is unique. We have already seen this in our RE-VERSE ADTM clinical study, which could enrol all adult patients taking Pradaxa® in need of reversal, and captured a broad variety of patients and situations. RE-VECTO is an additional program designed to further our understanding of the different situations in which Praxbind® is used in clinical practice. This will ultimately help improve care for patients treated with Pradaxa® in the rare event that reversal is needed.” 

The data for RE-VECTO will be captured through hospital pharmacies where Praxbind® is dispensed.5 The data collected will include anonymous information about the types of patients and situations in which Praxbind® was utilised.5 The data gathered from RE-VECTO will help shape future information and education on Praxbind® to healthcare providers and patients. 

Praxbind® is the first and only specific non-vitamin K antagonist oral anticoagulant (NOAC) reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of Pradaxa® is required.1,2 The efficacy and safety of idarucizumab continues to be evaluated in RE-VERSE AD™ - a Phase III global clinical trial.6 It is designed to evaluate the types of patients and real-world situations healthcare professionals may see in emergency settings.7,8 The broad inclusion criteria ensure that even the most severely ill or injured patients (e.g. patients with sepsis or a severe intracranial haemorrhage), who require urgent reversal of dabigatran, may be enrolled in the study.7,8,9 Results from an interim analysis of RE-VERSE AD™ showed that idarucizumab immediately reversed the anticoagulant effect of dabigatran even in critically ill and high-risk patients in emergency situations.7 

NOTES TO THE EDITORS 

About RE-VECTO
The global, multi-centre RE-VECTO Surveillance Program will collect data on Praxbind® usage patterns in a clinical practice setting.4 The program will enrol at least 300 patients, and all hospital pharmacies where Praxbind® is used are eligible to participate.3,5 Collected data will include information such as:

  • The hospital pharmacy dispensing Praxbind®
  • Patient characteristics
  • Why Praxbind® was used – which hospital department administered it, under what circumstances, total dose administered, timings of administration, and if any adverse events occurred.5

Study completion is expected by the end of 2018.3 

About Praxbind® (idarucizumab)
Praxbind® (idarucizumab) is a humanized antibody fragment, or Fab, designed as a specific reversal agent to dabigatran.10 Idarucizumab binds specifically to dabigatran molecules only, neutralising their anticoagulant effect without interfering with the coagulation cascade.8,10

Praxbind® is indicated for patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:

  • For urgent procedures / emergency surgery
  • In life-threatening or uncontrolled bleeding1,2

Phase I data in elderly and renally impaired volunteers showed that a 5 minute infusion of 5g idarucizumab led to immediate, complete and sustained reversal of dabigatran.11 

About the RE-VERSE AD™ study
RE-VERSE AD™ is a Phase III global study that includes patients taking dabigatran who require urgent procedures or have uncontrolled bleeding.6 It is designed to evaluate the types of patients and real-world situations healthcare professionals may see in emergency settings.7,8 The broad inclusion criteria ensure that even the most severely ill or injured patients (e.g. patients with sepsis or a severe intracranial haemorrhage), who require urgent reversal of dabigatran, may be enrolled in the study.7,8,9

Interim analyses of Phase III data from the emergency setting demonstrated that a single 5g dose of idarucizumab immediately reversed the anticoagulant effect of dabigatran in all patients evaluated.7,9 The interim analyses from RE-VERSE AD™ included data from patients requiring urgent procedures / emergency surgery, e.g. surgery for an open fracture after a fall, or patients with either uncontrolled or life-threatening bleeding complications, e.g. intracranial haemorrhage or severe trauma after a car accident.7,8,9  Thrombotic events occurred in five of the 123 enrolled patients between two to 24 days after idarucizumab administration.7 None of these patients were receiving antithrombotic therapy at the time of their event. There were 26 total deaths, which appeared to be related to the original reason for emergency admission to the hospital and/or to co-morbidities.7

The study is the first of its kind in patients, and has been underway since May 2014, enrolling up to 500 patients in more than 35 countries.3,6 

About Pradaxa® (dabigatran etexilate)
Clinical experience of dabigatran equates to over 6 million patient-years in all licensed indications worldwide. Dabigatran has been in the market for more than 7 years and is approved in over 100 countries.3

Currently approved indications for dabigatran are:

  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
  • Treatment of DVT and PE and the prevention of recurrent DVT and recurrent PE in adults12,13

Dabigatran, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.12,13,14 Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.15 In contrast to vitamin K antagonists, which variably act via different coagulation factors, dabigatran provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.14,16

About Boehringer Ingelheim 
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.

For more information please visit our company website www.boehringer-ingelheim.com

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

References

1.    Praxbind® European Summary of Product Characteristics, 2015.
2.    Praxbind® U.S. Prescribing Information, 2015.
3.    Boehringer Ingelheim. Data on file.
4.    RE-VECTO Surveillance Program: Evaluating the use of idarucizumab in a real-world setting. Available at: https://www.re-vecto.com/ Last accessed: July 2016.
5.    About the RE-VECTO Surveillance Program. Available at: https://www.re-vecto.com/about-the-program Last accessed: July 2016.
6.    Reversal of Dabigatran Anticoagulant Effect with Idarucizumab. Available at: https://clinicaltrials.gov/ct2/show/NCT02104947 Last accessed: July 2016.
7.    Pollack C.V. et al. Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Patients in an Emergency Setting of Major Bleeding, Urgent Surgery, or Interventions. 1130M-05. Presented on 2 April 2016 at the American College of Cardiology 65th Annual Scientific Session and Expo, Chicago.
8.    Pollack C. V. et al. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015;114(1):198-205.
9.    Pollack C. V. et al. Idarucizumab for Dabigatran Reversal. NEJM. 2015;373:511-520.
10.    Schiele F. et al. A specific antidote for dabigatran: functional and structural characterization. Blood. 2013;121(18):3554–62. 
11.    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. Blood. 2014; 124: Abstract 344.
12.    Pradaxa® European Summary of Product Characteristics, 2016.
13.    Pradaxa® U.S. Prescribing Information, 2015.
14.    Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
15.    Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353(10):1028–40.
16.    Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45(5):555–63.