Final Phase III Study Results Confirm Benefit of Praxbind® as Reversal Agent for Pradaxa® Patients in Emergency Situations
11.7.2017 11:31 | Business Wire
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
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.
Further Media Channels:
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.
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.
Boehringer Ingelheim GmbH
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
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
Major Terrorist Plot Foiled in Saudi Arabia, Ministry of Interior Announces21.7.2017 21:33 | Tiedote
The following is a statement from Saudi Arabia’s Ministry of Culture and Information: This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170721005575/en/ Weapons and other items found in the possession of the three terrorists are an indication of the ugliness and severity of the acts of terrorism they were planning to carry out, victimizing innocent lives and private and public property. (Photo: ME NewsWire) The Saudi Ministry of Interior has announced that a major terrorist attack was prevented by security services in the city of Saihat in the Qatif governorate. On the evening of Friday, July 14th, security services intercepted a stolen Toyota Corolla vehicle in a busy, built-up district of the city. As the stolen vehicle was surrounded by security services, three men in the ca
Janssen Receives Positive CHMP Opinion for SYMTUZA™ The First Darunavir-Based Single-Tablet Regimen for the Treatment of HIV21.7.2017 15:09 | Tiedote
Janssen-Cilag International NV (Janssen) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for SYMTUZA™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF]), a once-daily darunavir-based single tablet regimen (STR). If approved, it will be the only darunavir-based STR indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg, with genotypic testing guiding use. This STR combines the proven efficacy and durability of darunavir with the improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (tenofovir disoproxil fumarate), and will be the only treatment that could deliver the adherence advantag
Ipsen Receives Positive CHMP Opinion for Approval of Xermelo® (Telotristat Ethyl), for the Treatment of Carcinoid Syndrome Diarrhea in Patients Inadequately Controlled by Somatostatin Analogue Therapy21.7.2017 14:26 | Tiedote
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the approval of Xermelo® (telotristat ethyl) 250 mg three times a day (tid) for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union, as well as Norway, Liechtenstein and Iceland. David Meek, Chief Executive Officer of Ipsen, said: “The positive CHMP opinion for Xermelo ® is an important milestone towards providing innovative s
Schlumberger Announces Second-Quarter 2017 Results21.7.2017 14:00 | Tiedote
Schlumberger Limited (NYSE:SLB) today reported results for the second quarter of 2017. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2017 Mar. 31, 2017 Jun. 30, 2016
NRI Secure Launches Japan's First "Blockchain Assessment" Service21.7.2017 10:00 | Tiedote
NRI SecureTechnologies, Ltd. (President: Jun Odashima; hereinafter NRI Secure), a leading provider of information security solutions in Japan, has begun providing Japan’s first-ever*1 “Blockchain Assessment,” a security Assessment service designed for systems and services which use blockchain technology*2. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170721005012/en/ Overview of the "Blockchain Assessment" Service (Graphic: Business Wire) As the blockchain technology has become more widespread, the presence of security-related vulnerabilities has also become increasingly apparent. In particular, with regard to smart contracts, *3 one of a constituent element of services using the blockchain, a cyberattack carried out on any vulnerable programs could lead to major threats or eve
Business Figures for the First Half of 2017: Sartorius Continues to Grow21.7.2017 08:00 | Tiedote
Sartorius (FWB:SRT), a leading international laboratory and pharmaceutical equipment supplier, continues on the growth track. In the first half of 2017, solid organic business development and two acquisitions led to a significant increase in sales revenue and earnings1. "Sartorius has continued its dynamic, profitable development," said CEO and Executive Board Chairman Dr. Joachim Kreuzburg in commenting on the company's first-half performance. "Both divisions achieved solid organic growth in an environment that was especially challenging in North America, and have made quick progress in integrating the businesses most recently acquired. In the Lab Products & Services Division, the bioanalytics unit newly created by our acquisitions has already contributed significant revenues and earnings. We see further considerable growth potential ahead for this business just as for the
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