Boehringer Ingelheim updates U.S. prescribing information for Pradaxa with FDA

Boehringer Ingelheim has today announced that it has updated the US prescribing information for Pradaxa^® (dabigatran etexilate) in alignment with the US Food and Drug Administration (FDA) to affirm that "Pradaxa^® 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." This positive change to the US label is based upon the results of the pivotal RE-LY^® trial conducted in 18,000 patients with non-valvular atrial fibrillation, which demonstrated unequivocally the superior benefits offered by Pradaxa^® in terms of effective prevention of stroke. In addition, RE-LY^® demonstrated a significant benefit versus well controlled warfarin in life-threatening bleeding events, and major reductions in intracranial bleeding.

"Ischaemic strokes account for up to 92% of strokes suffered by patients with atrial fibrillation, often leading to severe debilitation and poor prognosis," said Hans-Christoph Diener, M.D., Ph.D., Professor and Chairman, Department of Neurology, University Duisburg-Essen, Germany. "For patients with atrial fibrillation, reducing the risk of stroke, especially ischaemic stroke, is the primary goal of anticoagulation treatment. It is important for both physicians and patients to have a treatment option that offers this decisive clinical benefit over warfarin when considering long term prevention from stroke."

Pradaxa^® 150mg bid is the only novel oral anticoagulant to have shown in a major study a significant reduction of both ischaemic and haemorrhagic strokes in patients with non-valvular atrial fibrillation when compared to warfarin. The RE-LY^® trial showed that Pradaxa^® 150mg bid reduced the risk of stroke and systemic embolism by 35% compared to well-controlled warfarin (INR 2-3, median TTR 67%). Furthermore, Pradaxa^® 110mg bid, which is indicated for certain patients, was shown to be as effective as well-controlled warfarin in the prevention of stroke and systemic embolism, while being associated with significantly lower major bleeding events in patients with non-valvular AF. RE-LY^® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.

"We welcome this update to the US prescribing information for Pradaxa^® which clearly demonstrates the unique benefit offered by this novel treatment to patients and physicians worldwide," said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "By significantly reducing both ischaemic and haemorrhagic strokes, and at the same time providing significant reductions in intracranial bleeding, Pradaxa^® 150mg twice daily has the potential to protect patients from catastrophic events better than warfarin."

The effectiveness and favourable safety profile of Pradaxa^® has been well documented in an extensive clinical trial programme, passing independent regulatory scrutiny and approval worldwide. Clinical experience of Pradaxa^® is already well established and continues to grow, equating to over 780,000 patient years in over 70 countries and exceeding that of all other novel oral anticoagulants. The launch of Pradaxa^® has been the most successful in the history of Boehringer Ingelheim and is among the pharmaceutical industry's top launches in the last decade.

Boehringer Ingelheim remains focused on both patient benefit and safety and is further investigating the profile of Pradaxa^® in the long-term safety study RELY-ABLE^®, the results of which will be presented later this year. Additionally, Boehringer Ingelheim recently launched Phase II of the GLORIA-AF^TM patient registry, which is designed to gain insights into the use of antithrombotic treatments in clinical practice to reduce the risk of stroke in patients with non-valvular atrial fibrillation.