Boehringer Ingelheim has announced that Pradaxa® will be commercially available in the UK for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of it’s recurrence, from July 14th.(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) Pradaxa® gained approval from the European Medicines Agency (EMA) in early June and was granted approval for the same indication by the US Food and Drug Administration earlier this year.(4)
Dr. David Keeling, Consultant Haematologist, Oxford University Hospitals NHS Foundation Trust said:
“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 Pradaxa® 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 Pradaxa®, compared to placebo.(6)
Additionally, the clinical trials showed that patients with DVT or PE taking Pradaxa® experienced lower rates of bleeding than those taking warfarin.(1,2,5-7) Pradaxa® 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 Pradaxa® 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
Pradaxa® 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 Pradaxa® 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)
Pradaxa® (dabigatran etexilate) 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)
- Boehringer Ingelheim. Pradaxa 110mg Summary of Product Characteristics. 2014. Available at: http://www.medicines.org.uk/emc/medicine/20760/SPC/. Last accessed: July 2014.
- Boehringer Ingelheim. Pradaxa 150mg Summary of Product Characteristics. 2014. Available at: http://www.medicines.org.uk/emc/medicine/24839/SPC/. Last accessed: July 2014.
- 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.
- 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.
- 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.
- 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.
- 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.
- The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 263:2499-2510.
- The EINSTEIN Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366:1287-1297.
- Agnelli G, Buller H, Cohen A et al. Apixaban for Extended Treatment of Venous Thromboembolism. N Engl J Med 2013; 368:699-708.
- 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.
- 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.
- Boehringer Ingelheim. Pradaxa 75mg Summary of Product Characteristics. 2014. Available at: http://www.medicines.org.uk/emc/medicine/20759/SPC/. Last accessed: July 2014.