OREANDA-NEWS. April 05, 2016.

About the RE-VERSE AD™ study
RE-VERSE AD™ is an ongoing phase III global study that includes patients taking dabigatran who require urgent procedures or have uncontrolled bleeding.4 The interim 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 haemorrhage or severe trauma after a car accident.1,4 The primary endpoint, the degree of reversal of the anticoagulant effect of dabigatran achieved by idarucizumab within four hours, was measured by diluted thrombin time (dTT) and ecarin clotting time (ECT).4

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.1.5

About idarucizumab (Praxbind®)
Idarucizumab is a humanized antibody fragment, or Fab, designed as a specific reversal agent to dabigatran.6 Idarucizumab binds specifically to dabigatran molecules only, neutralising their anticoagulant effect without interfering with the coagulation cascade.4,6

In the EU and U.S., idarucizumab is now indicated for patients treated with dabigatran when reversal of the anticoagulant effects of dabigatran is needed:2,3

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

Regulatory reviews and submissions in other countries are ongoing. Boehringer Ingelheim plans to submit idarucizumab in all countries where dabigatran is licensed.7

About dabigatran etexilate (Pradaxa®)
Clinical experience of dabigatran equates to over 5 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.7

Currently approved indications for dabigatran are:8,9

  • 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.8-10 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.11 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.10,12

Dabigatran is the only non-vitamin K antagonist oral anticoagulant with an approved reversal agent. Praxbind® (idarucizumab) is approved in the EU and U.S. 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.2,3

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is 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, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit 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.