Boehringer Ingelheim reports positive performance of Pradaxa reversal agent

Boehringer Ingelheim has announced the publication of clinical trial data that shows the effectiveness of idarucizumab, a specific reversal agent for the novel oral anticoagulant Pradaxa.

Published in The Lancet, the results from the healthy volunteer study showed the use of idarucizumab led to immediate, complete and sustained reversal of the anticoagulant effect of Pradaxa, with complete reversal achieved with a single five-minute infusion.

Moreover, the reversal effect was sustained for more than 24 hours for all doses of two grams and above, with the agent itself being well tolerated by the study participants.

Data from this trial will support the accelerated approval procedures that the manufacturer is pursuing with healthcare regulators in the US, Canada and Europe.

Professor Jorg Kreuzer, vice-president for the cardiovascular business at Boehringer Ingelheim, said: "Once approved, the availability of a specific reversal agent for a novel oral anticoagulant will be yet another landmark in anticoagulation care."

Pradaxa is one of Boehringer Ingelheim's most important products. The launch of a reversal agent will be of use in cases where its effects need to be undone for medical reasons.