Praxbind™ (idarucizumab), A Specific Antidote for Immediate Reversal of Pradaxa® (dabigatran etexilate)[1] Now Approved in Canada With Conditions

Praxbind™ provides immediate, complete and sustained reversal of the anticoagulant effects of Pradaxa® within minutes^1,2

BURLINGTON, ON, May 16, 2016 /CNW/ - Boehringer Ingelheim (Canada) Ltd. today announced that Health Canada has approved Praxbind™ (idarucizumab) with conditions. Praxbind™ is a specific antidote for the immediate reversal of dabigatran, and is indicated for adult patients treated with Pradaxa® (dabigatran etexilate) when rapid specific reversal of the anticoagulant effects of Pradaxa® is required for emergency surgery/urgent procedure or life-threatening or uncontrolled bleeding.¹ The approval with conditions is based on promising evidence from clinical trials. Pradaxa® is approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), in whom anticoagulation is appropriate.  The conditional approval of Praxbind™ makes Pradaxa® the first and only novel oral anticoagulant (NOAC) in Canada with a specific antidote.¹

"Patient safety is of utmost importance to Boehringer Ingelheim, and with the addition of Praxbind™ - we are providing greater peace of mind to thousands of AFib patients in Canada," says Richard Mole, President and CEO, Boehringer Ingelheim (Canada) Ltd.  "Life is unpredictable – making it difficult to know when an emergency might occur that requires urgent medical care and reversal of the blood-thinning effects of their anticoagulant. The approval of Praxbind™ provides healthcare professionals and patients with more confidence that the anticoagulant effects of Pradaxa® can be immediately reversed, if needed.  As we did with the introduction of Pradaxa® back in 2010, the first NOAC to be approved in Canada, we are again leading the evolution of anticoagulant care."

Novel oral anticoagulants have dramatically changed the way AFib is treated and managed.³ While it is evident that anticoagulant treatment reduces the risk of stroke, the fear of a potential bleed, or the need to rapidly reverse the effects of anticoagulant therapy, is the leading concern for under prescribing of OACs, as well as the lack of treatment adherence amongst patients taking OAC therapy to prevent a potentially devastating stroke.^4-7

"The availability of Praxbind for immediate reversal of Pradaxa is a major advancement in anticoagulation care," says Dr. John Eikelboom, Associate Professor, Department of Medicine, McMaster University in Hamilton.  "It gives the peace of mind some patients and physicians are looking for when using anticoagulation that there is an antidote for immediate reversal, if the need arises. In my experience, I can tell you that I've seen complete reversal of the anticoagulation effects of Pradaxa within minutes of administering Praxbind."   

Praxbind™ has been issued a conditional marketing authorization, pending the final clinical trial results to confirm its reversal effects in patients and promising evidence of clinical benefit.  Under this policy, Boehringer Ingelheim will provide Health Canada with the final clinical trial results of the case series study in patients when they are available.

To date, patient case series study results have demonstrated that 5 g of Praxbind™ provides immediate, complete and sustained reversal of the anticoagulant effects of Pradaxa®  in most patients requiring urgent intervention.^1,2

About AFib
Affecting 350,000 Canadians, AFib  is the most common type of irregular heartbeat⁸ and can lead to severe and debilitating strokes,⁹ placing people at a three to five times greater risk of stroke.¹⁰ While all oral anticoagulants are associated with an increased risk of bleeding, treatment with oral anticoagulants has been shown to reduce the risk of stroke.¹¹ 

About Praxbind™ (idarucizumab)
Praxbind™ is a humanized monoclonal antibody fragment that specifically binds to dabigatran to reverse the anticoagulant effects of Pradaxa®.¹ Praxbind™ does not reverse the effects of other anticoagulants.¹ 

Boehringer Ingelheim began research on Praxbind™ before the approval of Pradaxa® for the prevention of stroke and systemic embolism in adults with AFib, in whom anticoagulation is appropriate, in 2010.³

Praxbind™ continues to be evaluated in REVERSE-AD™, a case series study initiated by Boehringer Ingelheim in 2014 to investigate Praxbind™ in the emergency setting.¹  Up to 500 patients taking Pradaxa® aged 18 years or over are expected to be enrolled from more than 400 centres in 38 countries worldwide.^12-15

The safety and efficacy of Praxbind™ has been evaluated in 224 healthy subjects as part of placebo-controlled trials. In addition, 123 patients were included in an ongoing case series study who had life-threatening or uncontrolled bleeding or required emergency surgery or procedures and were on treatment with Pradaxa®.¹  Mild symptoms of hypersensitivity (fever, difficulty in breathing or wheezing increased frequency of rapid breathing, rash or itching) were also reported in these patients. These were reported in a clinical trial, but may not be directly related to Praxbind™.¹ 

In February and March 2015, Praxbind™ was submitted under an accelerated approval pathway to the U.S. Food and Drug Administration (FDA), European Medicines Agency and Health Canada for use in patients who require urgent reversal of Pradaxa®. Praxbind™ was approved by the US FDA in October, 2015, the European Medicines Agency in November, 2015, and Health Canada with conditions in April, 2016.^1,16,17 

About Pradaxa® (dabigatran etexilate)
Pradaxa® (dabigatran etexilate) was first approved for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.¹⁸  It was then approved for the prevention of stroke and systemic embolism in patients with AFib, in whom anticoagulation is appropriate.¹⁸ Pradaxa® was most recently approved for the treatment of venous thromboembolism events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PE.¹⁸  To date, over 130,000 Canadians with AFib have received Pradaxa® for stroke prevention.³

Pradaxa® has been on the market for more than seven years and is approved in over 100 countries.³

The efficacy and safety profiles of Pradaxa® in its licensed indications are well documented in an extensive clinical trial program.^19-26 In addition, the favourable benefit-risk profile of Pradaxa® is supported by safety assessments from regulatory authorities including the European Medicines Agency, the U.S. Food and Drug Administration (FDA), and INESSS in Canada.^27-30  In May 2014, in one of the largest real-world analyses of its kind, the FDA once again re-affirmed the favourable benefit/risk profile of Pradaxa® when it issued results from this study, including more than 134,000 patients.²⁹ The safety and efficacy profile of Pradaxa® has been supported by nearly 250,000 patients in the real world.^30-41

As the first direct oral anticoagulant to market, clinical experience with Pradaxa® continues to grow and equates to over five million patient-years in all licensed indications to date.³

For dosing, side effects, warnings and precautions, please refer to the Pradaxa® Product Monograph:  http://www.boehringeringelheim.ca/content/dam/internet/opu/ca_EN/documents/humanhealth/product_monograph/PradaxaPMEN.pdf

About 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 145 affiliates and a total of more than 47,500 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 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 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of its net sales.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada.

For more information please visit www.boehringer-ingelheim.ca

References

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SOURCE Boehringer Ingelheim (Canada) Ltd.

Robbyn Walsh, Environics Communications, 416-969-2759 / [email protected]; Jennifer Mota, Boehringer Ingelheim (Canada) Ltd, 905-631-4739 / [email protected]