INGELHEIM, Germany - Monday, November 18th 2013
AHA Congress 2013 - Positive results from first investigation in 145 healthy volunteers showed antidote to be well tolerated, producing immediate, complete and sustained reversal of dabigatran-induced anticoagulation1
Investigational antidote intended to further broaden the existing range of reversal options available to physicians during critical care situations
Pradaxa® (dabigatran exetilate) offers a favourable safety and efficacy profile as was shown during clinical trials and confirmed in real-world observations2-14
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Presented for the first time at the American Heart Association’s (AHA) Scientific Sessions, results from the first clinical study in healthy volunteers demonstrate the potential of an antibody fragment (Fab) as a specific antidote for immediate, complete and sustained reversal of dabigatran-induced anticoagulation.1 The development of the antidote is part of Boehringer Ingelheim’s commitment to further broadening the range of reversal options available to physicians in rare critical care situations. The antibody fragment has not yet been approved for clinical use and is still undergoing investigation to further establish its efficacy and safety profile.
The clinical study examined the safety, tolerability, pharmacokinetics and pharmacodynamics of the antibody fragment antidote in a randomised, double-blind, placebo controlled study involving 145 healthy male volunteers. In a first step, the tolerability of the antibody fragment was tested as an intravenous infusion of rising doses (up to 8 g). In a second step, the potential for reversal of dabigatran-induced anticoagulation was evaluated, with 5-minute infusions using three different doses (1 g, 2 g and 4 g) administered following Pradaxa® pre-treatment (220 mg twice daily for 3 days).1
The results demonstrated:1
All administered doses of the antibody fragment antidote were well tolerated
A 5-minute infusion of the antidote following Pradaxa® pre-treatment was able to achieve immediate, complete and sustained reversal of the anticoagulant effect of dabigatran
For the 2 g and the 4 g doses, the reversal effect was maintained for more than 12 hours after the end of infusion
“These first results from the clinical study investigating the antibody fragment as a specific antidote to dabigatran are very encouraging,” commented Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “Boehringer Ingelheim led the field by bringing the first novel oral anticoagulant treatment to patients with atrial fibrillation. As part of our commitment to scientific innovation, our scientists continue to conduct research to further improve the care of patients treated with Pradaxa® by broadening the range of reversal options that are available to them in clinical practice.”
The clinical development of the antibody fragment is ongoing. Boehringer Ingelheim is planning to initiate the next phase of investigation including studies in patients in 2014.
Preventing stroke is the primary goal of treatment in patients with atrial fibrillation for which anticoagulation therapy is essential.15,16 An increased risk of bleeding is a known possible treatment complication of all anticoagulant therapies.17 While no specific antidote is approved or available in clinical practice to counteract the anticoagulant effect of any novel oral anticoagulant therapy,18 well established measures are currently available for patients treated with Pradaxa® to reverse the anticoagulant effect or to manage bleeding during an emergency situation.19,20 A dedicated sub-analysis from the landmark RE-LY® trial showed that in RE-LY®, patients had better survival prognosis and spent less time in intensive care following a major bleed with Pradaxa® than with warfarin.21 It is expected that the development of a specific antidote to Pradaxa® will further broaden the range of reversal options available to physicians in clinical practice.
The efficacy and safety profile of Pradaxa® in its licensed indications is well documented in an extensive clinical trial programme,2-12 which has led to worldwide regulatory approvals in over 100 countries to date.22 This favourable efficacy-safety profile of Pradaxa® is supported by safety assessments from regulatory authorities including the European Medicines Agency and the U.S. Food and Drug Administration (FDA).13,14 Clinical experience with Pradaxa® continues to grow and equates to over 2 million patient-years in all licensed indications to date supporting Pradaxa® as the leading novel oral anticoagulant.23
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