Pradaxa® (dabigatran etexilate) now approved in over 100 countries for stroke prevention in atrial fibrillation
March 6, 2014 - Ingelheim, Germany And Jordan And Dubai, United Arab Emirates
For media outside of the US, the UK & Canada only
Over 100 countries have now approved Boehringer Ingelheim’s Pradaxa® for the prevention of stroke and systemic embolism for adult patients with the most common sustained heart rhythm condition (non-valvular atrial fibrillation, nvAF).1 The 100th approval was announced by the Jordan Food and Drug Administration. Further regulatory approvals for Pradaxa® are expected to be received in the near future. The continuous flow of regulatory approvals from health authorities all over the world reaffirms the overarching benefits delivered to patients by the treatment and supports previous announcements by the U.S. Food and Drugs Administration (FDA) and the European Medicines Agency (EMA).2,3 Pradaxa®, in addition, offers the most robust clinical data set and the longest real-world experience for stroke prevention in atrial fibrillation (SPAF) compared to any of the novel oral anticoagulants, providing ongoing support for physician use of the novel treatment.4-14
The efficacy and safety of Pradaxa® was established in the RE-LY® trial, one of the largest stroke prevention clinical studies ever conducted in patients with AF.5,6 Pradaxa® 150mg bid is the only novel oral anticoagulant, study of which has shown a significant reduction in the incidence of ischaemic strokes in patients with non-valvular AF compared to warfarin, offering a relative risk reduction of 25 percent.5,6
With over nine out of ten strokes suffered by patients with AF being of ischaemic type,15 protection against ischaemic stroke is the key clinical benefit that should be achieved by anticoagulant treatment.16,17 Ischaemic strokes associated with AF are often fatal, and those patients who survive are on average left more disabled by their stroke and have a higher likelihood of stroke recurrence than patients with other causes of stroke.18,19
“Passing the landmark 100th approval of Pradaxa® for stroke prevention and with still more on the horizon, we come close to saying that this novel treatment can benefit patients around the world,” commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “The regulatory approval achieved in Jordan, in addition to those achieved with 100 other health authorities around the world, speaks volumes. It also indicates the breadth of benefits that Pradaxa® offers to AF patients, including superior protection against ischaemic stroke compared to warfarin.”
Boehringer Ingelheim led the anticoagulant field by bringing Pradaxa®, the first novel oral anticoagulant for stroke prevention in atrial fibrillation, to market.20 Pradaxa® is the only novel oral anticoagulant with more than 6 years of long-term data supporting its beneficial role in this patient population,4 in addition to over 2.7 million patient-years of clinical experience in all licensed indications to date,1 making Pradaxa® the leading novel oral anticoagulant.
In November 2013 Boehringer Ingelheim announced plans to initiate two large, global clinical trials evaluating its efficacy and safety in stroke prevention therapy in two clinically highly relevant conditions. The RE-SPECT ESUS™ trial will investigate the efficacy and safety of dabigatran etexilate in patients whose first stroke was of embolic origin with unknown source (ESUS). The RE-DUAL PCI™ trial will evaluate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stenting. The trials are scheduled to begin enrolment in mid-2014 and respectively, early 2015 and will form part of the extensive RE-VOLUTION® clinical trial programme.
A large programme to gather real world data in clinical practice, the GLORIA™-AF Registry Program is running as one of the largest registries in newly diagnosed patients with irregular heart beat (non-valvular atrial fibrillation) at risk for stroke. GLORIA™-AF is designed to investigate patient characteristics influencing choice of antithrombotic treatment for stroke prevention in atrial fibrillation and to assess the relative long-term effectiveness and safety of Pradaxa® vs. warfarin. It is expected to provide meaningful knowledge on the global role and use of antithrombotic treatments for stroke prevention in patients with nvAF across different regions of the world.21
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Source: Business Wire India