Boehringer Ingelheim seeks approval of Pradaxa reversal agent

Boehringer Ingelheim has filed for regulatory approval of an investigational specific reversal agent for its anticoagulant Pradaxa in Europe, the US and Canada.

The compound idarucizumab has been submitted for approval of marketing authorisation to the European Medicines Agency, the US Food and Drug Administration and Health Canada. It has already received breakthrough therapy designation in the US.

The submission is for use in patients who require rapid reversal of the anticoagulant effect of dabigatran, the active ingredient in Pradaxa. It has already shown efficacy in a range of patients, including elderly and renally impaired individuals.

It marks the first regulatory submission of an investigational specific reversal agent to a novel oral anticoagulant.

Professor Jorg Kreuzer, vice-president for Boehringer Ingelheim's cardiovascular business, said: "Our discovery and development of idarucizumab in-house is an example of our company's dedication to the evolution and innovation of anticoagulation care."

Pradaxa has been in the market for more than six years and is approved in over 100 countries. Clinical experience of the anticoagulant equates to more than 3.9 million patient-years in all licensed indications worldwide.