Boehringer Ingelheim files for approval of Pradaxa reversal agent

Boehringer Ingelheim has filed for regulatory approval of an investigational specific reversal agent to its novel oral anticoagulant Pradaxa.

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, with accelerated procedures being pursued with all three authorities.

In phase I trials, idarucizumab has shown immediate, complete and sustained reversal of the anticoagulant effect of Pradaxa, with no pro-thrombotic effect. Boehringer Ingelheim is currently conducting phase III studies to offer further evidence to support its applications.

This represents the first instance of a company applying for regulatory approval of a specific reversal agent to a novel oral anticoagulant.

Professor Jorg Kreuzer, vice-president for the cardiovascular medicine therapeutic area at Boehringer Ingelheim, 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 is a direct thrombin inhibitor and was the first widely approved drug in a new generation of direct oral anticoagulants. Idarucizumab will be a valuable tool for use in cases where its effects need to be reversed for medical reasons.