Boehringer Ingelheim study shows rapid action of Pradaxa reversal agent

Boehringer Ingelheim has announced new phase III clinical trial data showing the rapid efficacy of idarucizumab, its new reversal agent for the novel oral anticoagulant Pradaxa.

Findings from the RE-VERSE AD patient study demonstrate that five grams of idarucizumab reversed the anticoagulant effect of Pradaxa in patients requiring urgent anticoagulant reversal within minutes, with no safety concerns identified.

RE-VERSE AD is the first study investigating the effect of a specific reversal agent to a novel oral anticoagulant with patients in a real-world setting, with this new interim analysis including data on 90 individuals.

The agent has been accepted for an accelerated review process in both the US and Europe.

Professor Jorg Kreuzer, vice-president for the cardiovascular medicine therapeutic area at Boehringer Ingelheim, said: "The real-world results from RE-VERSE AD are extremely encouraging and demonstrate how idarucizumab can support patient management during emergency situations."

Boehringer Ingelheim began research on idarucizumab in 2009, before the first marketing authorisation of Pradaxa for stroke prevention in atrial fibrillation was granted in 2010.