Boehringer Ingelheim has announced that Pradaxa 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 Tuesday.
DVT and PE are dangerous conditions, with over 25,000 deaths estimated to occur in hospitalized patients each year in the UK. Pradaxa 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.
Dr. David Keeling, consultant hematologist, 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.”
European approval is based on results from three Phase 3 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. In a fourth trial, data showed a reduction in the risk of recurrent DVT and PE in patients treated with Pradaxa, compared to placebo.
Additionally, the clinical trials showed that patients with DVT or PE taking Pradaxa experienced lower rates of bleeding than those taking warfarin. Pradaxa has the longest clinical trial experience in DVT and PE patients of any novel oral anticoagulant.
“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.”
Date: July 15, 2014
Source: Boehringer Ingelheim