Business Wire

Final Phase III Study Results Confirm Benefit of Praxbind® as Reversal Agent for Pradaxa® Patients in Emergency Situations

Jaa

Boehringer Ingelheim today announced final results from RE-VERSE AD.1,2 The study shows that Praxbind® (idarucizumab) was able to immediately and completely reverse the anticoagulant effect of Pradaxa® (dabigatran etexilate) in patients in emergency situations. The effects were consistent both in patients requiring an urgent surgery or intervention, and in patients presenting with uncontrollable or life-threatening bleeding. The reversal of the anticoagulant effect of Pradaxa® allowed physicians to quickly initiate necessary emergency interventions.1,2 The findings were presented at the International Society on Thrombosis and Haemostasis (ISTH) 26th Biennial Congress in Berlin, Germany and simultaneously published in the New England Journal of Medicine.1,2

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170711005676/en/

The primary endpoint of RE-VERSE AD was reversal of the anticoagulant effect of Pradaxa® within four hours as measured by diluted thrombin time (dTT) and ecarin clotting time (ECT), and was observed in 100 percent of patients (95 percent CI, 100-100). Reversal became evident immediately after administration of Praxbind® and was maintained for 24 hours in most patients. Reversal was independent of age, sex, kidney function or dabigatran concentration at baseline.1,2 A single 5 g dose of Praxbind® was sufficient in 98 percent of patients.

The clinical outcomes captured as secondary endpoints provide insights into the clinical relevance of anticoagulation reversal:1,2 in patients enrolled with acute bleeding (Group A), who could be assessed for time to cessation of bleeding, it took a median of 2.5 hours until the bleeding had stopped; in patients enrolled with a need for urgent surgery or intervention (Group B), the required procedures could be initiated after a median of 1.6 hours. In 93.4 percent of patients requiring procedures, haemostasis during the procedure was described as normal.1,2

“Emergencies or accidents can happen to anyone. Patients with atrial fibrillation on an anticoagulant may feel anxious about how they might be managed in an emergency,” Professor Charles Pollack, lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, USA commented. “RE-VERSE AD has shown that idarucizumab reverses the anticoagulant effect of dabigatran within minutes and provides immediate, complete and sustained reversal of dabigatran, so that treating physicians can fully focus on dealing with the emergency at hand.”

There were no serious adverse safety signals related to Praxbind® observed in the study. Patients in this study were elderly, had numerous comorbidities and presented with serious index events such as intracranial hemorrhage, multiple trauma or sepsis. Mortality rates at 90 days were 18.8 percent (Group A) and 18.9 percent (Group B). At 90 days, thrombotic events had occurred in 6.3 percent of Group A patients and 7.4 percent of Group B patients, which is consistent with rates reported after major surgical procedures or hospitalisation for uncontrolled bleeding in patients who had taken a vitamin K antagonist.1,2

“These final data from RE-VERSE AD fully confirm our interim insights,” Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim commented. “The good news for patients and physicians is that Praxbind® is already approved in 61 countries and is available in more than 8,200 sites worldwide, where it can be used to treat patients when urgently needed.”

Praxbind® is the first and only approved specific reversal agent for a non-vitamin K antagonist oral anticoagulant currently available. Boehringer Ingelheim continues to study Praxbind® in the RE-VECTO programme, which evaluates usage patterns in a clinical practice setting. Expected completion of the RE-VECTO programme is the end of 2018.5

~ENDS~

NOTES TO THE EDITORS

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.1,2,6 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.1,2 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.1,2

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:1,2,6

  • 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 Praxbind ® (idarucizumab)

Praxbind® (idarucizumab) is a humanised antibody fragment, or Fab, designed as a specific reversal agent to dabigatran.7 Idarucizumab binds specifically to dabigatran molecules only, neutralising their anticoagulant effect without interfering with the coagulation cascade.6,7

In 61countries around the world, Praxbind® is now indicated for patients treated with dabigatran when reversal of the anticoagulant effects of Pradaxa® is needed:3,4

  • 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.8

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.8

Currently approved indications for Pradaxa® are:9,10

  • 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.9-11 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.12 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.11,13

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.3,4

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.

Further Media Channels:
www.facebook.com/boehringeringelheim
www.twitter.com/Boehringer
www.youtube.com/user/boehringeringelheim
www.youtube.com/user/CVTV
www.pinterest.com/biglobal
www.instagram.com/boehringer_ingelheim

References
1. 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.
2. 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
3. Idarucizumab European Summary of Product Characteristics, 2016.
4. Idarucizumab US Prescribing Information 2015.
5. https://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-launches-re-vecto-global-program
6. 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.
7. Schiele, F. et al. A specific antidote for dabigatran: functional and structural characterization. Blood. 2013;121(18):3554-62.
8. Boehringer Ingelheim. Data on File.
9. Pradaxa® US Prescribing Information, 2015.
10. Pradaxa® European Summary of Product Characteristics, 2016.
11. Stangier, J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
12. Di Nisio, M. et al. Direct thrombin inhibitors. N Engl J Med.2005;353:1028–40.
13. 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.

Contact information

Boehringer Ingelheim GmbH
Friederike Middeke
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
E-mail: press@boehringer-ingelheim.com
Twitter:  http://twitter.com/Boehringer
or
More information
www.boehringer-ingelheim.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

GTIS Partners Clinches Sustainability Performance Top Honors for Third Year Running20.9.2017 16:32Tiedote

GTIS Partners LP (“GTIS”), a real estate private equity firm headquartered in New York City, with offices in São Paulo, Los Angeles, San Francisco, Atlanta, Paris and Munich, today announced that the GTIS Brazil Real Estate Fund I has been recognized as 2017’s most sustainable private equity real estate investment fund in South America by the Global Real Estate Sustainability Benchmark (GRESB). This is the third year in a row that the fund has taken top honors. In addition, GRESB awarded GTIS Brazil Real Estate Fund II first place in the specialized category of non-listed real estate funds with hotel concentrations, and a number two ranking overall. GTIS Brazil Real Estate Fund III, which held its final closing in December 2016 with approximately $680 million in commitments, took third place. “GTIS Partners received another top honor with the #1 rank for South America in the

The Meet Group to Acquire LOVOO20.9.2017 15:31Tiedote

The Meet Group, Inc. (NASDAQ:MEET), a public market leader in the mobile meeting space, today announced it has executed a definitive agreement to acquire LOVOO, a social dating app, for $70 million in cash, inclusive of a $5 million contingent earn-out. This acquisition furthers The Meet Group’s strategy to innovate, acquire, and build the largest mobile portfolio of brands for meeting new people. The LOVOO acquisition is expected to expand The Meet Group’s global footprint, increase the company’s scale and profitability, and diversify its business model by adding expertise in subscription and in-app purchasing. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005645/en/ LOVOO is a social and mobile technology company based in Germany: The #1 Dating App in German speaking countries (Ger

Arthur D. Little Urges Network Operators to Prepare for Next-Generation Internet of the GigaWorld20.9.2017 14:00Tiedote

In its new report, “Unlocking GigaWorld Innovation: GigaApps in a GigaWorld,” Arthur D. Little (ADL) outlines the investment and monetization opportunities available to network operators ready to embrace the “GigaWorld”, the emerging third cycle of the internet. Defined by continuous and intelligent collaboration between individuals, devices and the built environment – and driven by applications in the areas of augmented reality, virtual telepresence and automated living – the GigaWorld has the potential to both power our economy and change the way we live. However, for it to be fully realized, network operators need to deliver improved Quality of Experience (QoE) for consumers and new Quality of Service (QoS) features for content and service providers. While operators have focused on delivering sufficient bandwidth and coverage to drive the current iteration of the internet, the GigaWorld

LINTEC Announces Four New Adhesive Materials for Labels20.9.2017 13:45Tiedote

LINTEC Corporation (TOKYO: 7966) announced on September 20 that it will launch four newly developed label adhesive materials sequentially from October 2017. The new products will be on display prior to launch at Labelexpo Europe 2017, the world’s largest trade show in the label field. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005611/en/ LINTEC's super-strength adhesive labelstocks (Photo: Business Wire) Overview of Labelexpo Europe 2017 Date: September 25 (Mon.) to 28 (Thurs.) Venue: Brussels Expo, Belgium LINTEC Booth: Hall 3 3C 15 LINTEC Press Conference: 11:00 a.m. to 11:30 a.m., September 25, held in the Brussels Expo Press Office Theater Super-strength adhesive labelstocks: Extreme adhesion for rough surfaces Charac

EGS Invests in Artificial Intelligence from Quintiq20.9.2017 13:05Tiedote

Quintiq, a Dassault Systèmes brand and global leader in supply chain planning and optimization (SCP&O), announces that it has partnered with European Gateway Services (EGS) to bring a new level of intelligence to intermodal logistics. European Gateway Services (EGS) offers the market an integrated network for transport to and from the European hinterland. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005578/en/ EGS invests in artificial intelligence from Quintiq (Photo: Business Wire) To better support its customers, EGS takes standard planning strategies to a new level with a synchromodal trip optimizer using Quintiq’s planning and optimization software, which employs artificial intelligence to choose the optimal modes and routes at all times. Quintiq technology makes s

EchoStar 105/SES-11 Shipped from Toulouse to the Cape for SpaceX Launch20.9.2017 12:03Tiedote

SES, EchoStar Corp., and Airbus Defence and Space announced today that the new EchoStar 105/SES-11 spacecraft, built by Airbus, has been shipped from the Airbus facilities in Toulouse, France, to Cape Canaveral, Florida, for its forthcoming launch by SpaceX in October. The first satellite that EchoStar has constructed with manufacturer Airbus, EchoStar 105/SES-11 will be launched by SpaceX on a flight-proven Falcon 9 rocket from Launch Complex 39A at Kennedy Space Center, Florida. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170920005539/en/ EchoStar 105/SES-11 Shipped from Toulouse to the Cape for SpaceX Launch (Photo: Business Wire) EchoStar 105/SES-11, a high-powered hybrid Ku and C-band communications satellite, is a dual-mission satellite for US-based operator EchoStar and Luxembourg-based

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme