Healthcare Industry News:  total knee 

Biopharmaceuticals Regulatory

 News Release - July 15, 2014

Pradaxa(R) (dabigatran etexilate) Now Available in the UK for the Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) and Prevention of Recurrence

PradaxaŽ is as effective as warfarin in the treatment and secondary prevention of DVT and PE with significantly fewer major, or clinically relevant non-major bleeds, compared to warfarin1,2

BRACKNELL, England, July 15, 2014 -- (Healthcare Sales & Marketing Network) -- Boehringer Ingelheim has announced that PradaxaŽ will be commercially available in the UK for the treatment of DVT and PE and the prevention of recurrent DVT and PE in adults, from today.1,2

DVT and PE are dangerous conditions, with over 25,000 deaths estimated to occur in hospitalised patients each year in the UK.3 PradaxaŽ gained approval from the European Medicines Agency (EMA) in early June and was granted approval for the same indication by the U.S. Food and Drug Administration earlier this year.4

Dr. David Keeling, Consultant Haematologist, Oxford University Hospitals NHS Foundation Trust.

"Over 120,000 people in the UK are affected by DVT and PE every year and it remains one of the most preventable causes of death in patients admitted to hospital. Having novel oral anticoagulants approved and available for the treatment of venous thromboembolism as well as atrial fibrillation means the care of patients with thrombosis can also be simplified. With a predictable anticoagulation effect, routine anticoagulant monitoring becomes a thing of the past, and with few drug and no food interactions the simplicity of the new anticoagulants will appeal greatly to patients and doctors alike."

Clinical trial programme

European approval is based on results from three Phase III clinical trials that demonstrated the efficacy of PradaxaŽ in the treatment of DVT and PE and prevention of recurrent DVT and PE in adults, compared to warfarin.5-7 In a fourth trial, data showed a reduction in the risk of recurrent DVT and PE in patients treated with PradaxaŽ, compared to placebo.6

Additionally, the clinical trials showed that patients with DVT or PE taking PradaxaŽ experienced lower rates of bleeding than those taking warfarin.1,2,5-7 PradaxaŽ has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant (NOAC).8-11

"We are delighted at the European Commission's decision to approve PradaxaŽ as it has demonstrated efficacy in the treatment of DVT and PE and prevention of recurrence, while also offering convenience through a fixed dose regimen that doesn't require routine anticoagulation monitoring," said Dr. Charles de Wet, UK Medical Director at Boehringer Ingelheim. "We are confident this decision will be similarly welcomed by both patients and clinicians."

Clinical convenience and reliability

PradaxaŽ is convenient for patients as, unlike warfarin, it does not require routine anticoagulation monitoring.1,2,12 Patients with DVT or PE can start taking PradaxaŽ in a fixed dose regimen after initial treatment with an injectable anticoagulant such as low-molecular-weight heparin (LMWH) for at least five days.1,2

PradaxaŽ has been available for over six years and is approved in more than 100 countries for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for primary prevention of VTE (venous thromboembolism, the collective term for DVT and PE) in patients who have undergone elective total hip or total knee replacement surgery.1,2,13

NOTES TO THE EDITORS

About PradaxaŽ (dabigatran etexilate)

PradaxaŽ has been in the market for more than six years and is approved in over 100 countries. The currently approved indications in Europe for PradaxaŽ (75 mg, 110 mg and 150 mg doses) are:1,2,13
  • 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 or knee replacement surgery


110 mg and 150 mg doses of PradaxaŽ are further approved for:1,2
  • Treatment of DVT and PE and the prevention of recurrent DVT and PE in adults


PradaxaŽ, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to address the high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.14,15 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.14,15

Vitamin-K antagonists, such as warfarin, act differently to direct thrombin inhibitors by interfering with the cyclic interconversion of vitamin K and its 2,3 epoxide (vitamin K epoxide).16 Although effective, these agents have numerous limitations such as a slow onset of action and variable dose requirements as a result of, in part, differences in dietary intake of vitamin K and numerous drug-drug interactions.17 PradaxaŽ provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no known drug-food interactions, without the need for routine coagulation monitoring.1,2,13,14

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 142 affiliates and a total of more than 47,400 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.

Taking 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 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

For more information please visit http://www.boehringer-ingelheim.com

References

(1) Boehringer Ingelheim. Pradaxa 110mg Summary of Product Characteristics. 2014. Available at: http://www.medicines.org.uk/emc/medicine/20760/SPC/. Last accessed: July 2014.

(2) Boehringer Ingelheim. Pradaxa 150mg Summary of Product Characteristics. 2014. Available at: http://www.medicines.org.uk/emc/medicine/24839/SPC/. Last accessed: July 2014.

(3) House of Commons. Health - Second Report. 2005. Available at: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/99/9902.htm. Last accessed: July 2014.

(4) Boehringer Ingelheim. Pradaxa U.S. Prescribing Information. 2014. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s018lbl.pdf. Last accessed: July 2014.

(5) Schulman S, Kearon C, Kakkar A et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009; 361:2342-2352.

(6) Schulman S, Kearon C, Kakkar A et al. Extended Use of Dabigatran, Warfarin or Placebo in Venous Thromboembolism. N Engl J Med 2013; 368:709-718.

(7) Schulman S, Kakkar A, Goldhaber G et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014; 129:764-772.

(8) The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 263:2499-2510.

(9) The EINSTEIN Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366:1287-1297.

(10) Agnelli G, Buller H, Cohen A et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med 2013; 368:699-708.

(11) Agnelli G, Buller H, Cohen A et al. Oral Apixaban for the Treatment of Acute Venous Thromboembolism. N Engl J Med 2013; 369:799-808.

(12) Amdipharm Mercury Company Limited. Marevan (warfarin) 5mg Summary of Product Characteristics. 2014. Available at: http://www.medicines.org.uk/emc/medicine/21596/SPC/. Last accessed: July 2014.

(13) Boehringer Ingelheim. Pradaxa 75mg Summary of Product Characteristics. 2014. Available at: http://www.medicines.org.uk/emc/medicine/20759/SPC/. Last accessed: July 2014.

(14) Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008; 47(5):285-295.

(15) Di Nisio M, Middeldorp S, Buller H.R. Direct thrombin inhibitors. N Engl J Med 2005; 353:1028-1040.

(16) Hirsh J, Dalen J, Anderson D et al. Oral anticoagulants: mechanism of action, clinical effectiveness, and optimal therapeutic range. Chest 2001; 119:8S-21S.

(17) Eikelboom J, Weitz J. Update on antithrombotic therapy. Circulation 2010; 121:1523-1532.

More information

http://www.boehringer-ingelheim.co.uk

@BoehringerUK


Source: Boehringer Ingelheim

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