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Boehringer Ingelheim. (11/14/17). "Press Release: New RE-VERSE AD Analyses Provide Additional Insights on Impact of Praxbind (idarucizumab) in Pradaxa (dabigatran etexilate) Patients with Gastrointestinal Bleeding or Needing Emergency Surgery". Ingelheim

Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 Thomas Jefferson University
Products Product Praxbind®
  Product 2 Pradaxa®
     


> Additional analyses of patients in diverse emergency settings confirm that idarucizumab immediately reverses the anticoagulant effect of dabigatran in patients in emergency settings1,2

> Sub-analyses from RE-VERSE AD™, the largest study to investigate a reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC), presented at the American Heart Association Scientific Sessions 20171,2


Boehringer Ingelheim announced results from two sub-analyses of the phase III RE-VERSE AD™ study.1,2 The sub-analyses evaluated the safety and efficacy of idarucizumab (marketed as Praxbind®) in reversing the anticoagulant effect of dabigatran etexilate (marketed as Pradaxa®) in patients in diverse emergency situations. These include those with acute bleeding or requiring an urgent surgery or procedure, such as an orthopedic, vascular or abdominal procedure. The analyses were presented at the American Heart Association (AHA) Scientific Sessions 2017 in Anaheim, California, USA. They provide further insights on the use of idarucizumab in patients with gastrointestinal (GI) bleeding and in those with a need for urgent surgery or intervention.

“The RE-VERSE AD study has demonstrated that idarucizumab can reverse the anticoagulant effect of dabigatran within minutes, allowing physicians to quickly initiate emergency interventions for patients who need urgent surgery or are experiencing uncontrollable bleeding,” said Charles Pollack, M.D., lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, USA. “These new analyses further reinforce the potential for idarucizumab to enhance care for people living with atrial fibrillation.”

One of the sub-analyses focused on patients with GI bleeding,2 the most common type of bleeding event among patients who were enrolled in the study due to acute bleeding. Of the 137 patients enrolled with a GI bleed, complete reversal of the anticoagulant effect of dabigatran was observed in more than 95 percent of patients. The median time to cessation of bleeding post-idarucizumab administration was less than three hours when the location of the GI bleed was known and 6.4 hours when the location was unknown.

Mortality and thromboembolic event rates for patients with a GI bleed were consistent with the overall findings of RE-VERSE AD. In the sub-analysis, as presented in the abstracts, at 90 days, there were low thromboembolic event rates of 5.1 percent in patients with a GI bleed, compared to 6.3 percent in non-GI bleed patients. Mortality in the first five days following administration was 6 percent in patients with a GI bleed, compared to 9 percent in non-GI bleed patients. At 90 days, mortality rates were 16 percent and 23 percent, respectively.2

Also presented at AHA were updated results assessing periprocedural bleeding in patients requiring an urgent procedure, such as an emergency surgery.1 Idarucizumab rapidly and completely reversed the anticoagulant effect of dabigatran in approximately 98 percent of patients based on diluted thrombin time (dTT). The median time between administration of idarucizumab and start of surgery was 1.7 hours for patients requiring abdominal procedures, 1.9 hours for orthopaedic procedures, 1.4 hours for vascular procedures, 1.3 hours for drainage procedures and 1.2 hours for catheter procedures. Among these patients, periprocedural bleeding was assessed as normal (if anticoagulation were absent) in more than 92 percent of patients, across all surgery types. Among patients needing emergency surgery, none were assessed as experiencing periprocedural bleeding that was severely abnormal (severe refractory hemorrhage). RE-VERSE AD™ is the only study to investigate anticoagulation reversal among patients requiring surgery.

“The RE-VERSE AD sub-analyses presented at the AHA Scientific Sessions provide insights in two highly relevant areas for patients and physicians,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Accidents can happen in life, also to patients taking an anticoagulant. Knowing that a fast-acting reversal agent is available is very reassuring to patients and their treating physicians. That is why we continue our efforts to expand the global availability of idarucizumab, the reversal agent for dabigatran.”


NOTES TO EDITORS


About Praxbind® (idarucizumab)

Praxbind® (idarucizumab) is a humanised antibody fragment, or Fab, designed as a specific reversal agent to dabigatran.3 Idarucizumab binds specifically to dabigatran molecules only, neutralising their anticoagulant effect without interfering with the coagulation cascade.3,4

Praxbind® is the first and only approved specific reversal agent for a non-vitamin K antagonist oral anticoagulant currently available. Being stocked in more than 8,500 sites around the world, Praxbind® is now indicated for patients treated with dabigatran in 61 countries when reversal of the anticoagulant effects of Pradaxa® is needed:5,6

For urgent procedure/emergency surgery
In life-threatening or uncontrolled bleeding

Regulatory reviews and submissions in other countries are ongoing. Boehringer Ingelheim plans to make Praxbind® available in all countries where Pradaxa® is licensed.7


About RE-VERSE AD™

RE-VERSE AD™ is a Phase III global study of patients taking dabigatran who require urgent procedures or have uncontrolled bleeding.4,8,9 The final analysis 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 hemorrhage or severe trauma after a car accident.8,9 The primary endpoint, the degree of reversal of the anticoagulant effect of dabigatran (Pradaxa®) achieved by idarucizumab (Praxbind®) within four hours, was measured by dTT and ECT.8,9

The study, which began in May 2014, is the largest study to investigate a reversal agent for a non-vitamin K antagonist oral anticoagulant (NOAC) in real-world emergency settings. It enrolled a total of 503 patients at 173 sites in 39 countries, which were included in one of two groups:4,8,9

> Group A: 301 patients (60 percent) presenting with uncontrolled or life-threatening bleeding (e.g. gastrointestinal [GI] and intracranial [ICH] bleeds)
> Group B: 202 patients (40 percent) requiring an invasive procedure or an emergency surgery or intervention (e.g. because of a hip fracture)

About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® equates to over 6.9 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than eight years and is approved in over 100 countries.7

Currently approved indications for Pradaxa® are:10,11

> 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 adults

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.12-14 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.12,14

Pradaxa® is the only novel oral anticoagulant with an approved reversal agent. Praxbind® is approved in the European Union and United States for adult patients treated with Pradaxa® who require rapid reversal of its anticoagulant effects prior to urgent procedures/emergency surgery or in life threatening or uncontrolled bleeding.5,6


About Boehringer Ingelheim

Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 percent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.

More information about Boehringer Ingelheim can be found on www.boehringer-ingelheim.com or in our annual report: http://annualreport.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. Levy J et al. Idarucizumab in dabigatran-treated patients requiring emergency surgery or intervention: Updated/final results from the RE-VERSE AD study. AHA Scientific Sessions 2017, Anaheim, California, Oral presentation 297 on Nov 13, Abstract15113.
2. Huisman MV et al. Idarucizumab is effective and safe in the inhibition of dabigatran anticoagulation in patients presenting with a gastrointestinal bleeding: Insights from the RE-VERSE AD study. AHA Scientific Sessions 2017, Anaheim, California, Poster presentation 5003 on Nov 13, Abstract 16489.
3. Schiele, F. et al. A specific antidote for dabigatran: functional and structural characterization. Blood. 2013;121(18):3554-62.
4. 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.
5. Idarucizumab European Summary of Product Characteristics, 2016.
6. Idarucizumab US Prescribing Information 2015.
7. Boehringer Ingelheim. Data on File.
8. Pollack, C.V. et al. Final Results of RE-VERSE AD Study: Reversal of Dabigatran by its Specific Reversal Agent Idarucizumab in Patients with Uncontrolled Bleeding or Requiring Urgent Surgery/Procedures. International Society on Thrombosis and Haemostasis (ISTH) 26th Biennial Congress and 63rd Annual Scientific and Standardization Committee (SSC), Berlin, July 2017, Late-breaking abstract 01.4.
9. Pollack, C.V. et al. Idarucizumab for Dabigatran Reversal – Full Cohort Analysis. New Engl J Med. 2017; DOI: 10.1056/NEJMoa1707278. www.nejm.org/doi/full/10.1056/NEJMoa1707278
10. Pradaxa® US Prescribing Information, 2015.
11. Pradaxa® European Summary of Product Characteristics, 2016.
12. Stangier, J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
13. Di Nisio, M. et al. Direct thrombin inhibitors. N Engl J Med.2005;353:1028–40.
14. 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;45:555–63.

   
Record changed: 2017-11-22

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