Boehringer Ingelheim announced that its 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) has now approved more than 100 countries.

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 US Food and Drugs Administation (FDA) and the European Medicines Agency (EMA).

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.

The efficacy and safety profile of Pradaxa was established in the RE-LY trial, one of the largest stroke prevention clinical studies ever conducted in patients with AF. 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 per cent.

With over nine out of ten strokes suffered by patients with AF being of ischaemic type, protection against ischaemic stroke is the key clinical benefit that should be achieved by anticoagulant treatment. 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.

"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. This is a reflection of 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 NOAC for stroke prevention in atrial fibrillation, to market. Pradaxa is the only novel oral anticoagulant with more than 6 years of long-term data supporting its beneficial role in this patient population, 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 Pradaxa’s 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 early 2015, respectively, 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 (dabigatran etexilate) 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.

Clinical experience of Pradaxa (dabigatran etexilate) exceeds that of all other novel oral anticoagulants, equating to over 2.7 million patient-years in all licensed indications worldwide. Pradaxa has already been in the market for more than 5 years and is approved in over 100 countries. Currently approved indications for Pradaxa are: Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) and a risk factor for stroke;     Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery; Primary prevention of venous thromboembolic events in patients undergoing elective total knee replacement surgery.

In June 2013 Boehringer Ingelheim started submitting new applications to regulatory authorities for Pradaxa for the indications:Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death; Prevention of recurrent deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and related death.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees.