Anticoagulant Reversal Agent Under FDA Review

Boehringer Ingelheim recently submitted a biologics license application (BLA) to the FDA requesting accelerated approval of its investigational drug, idarucizumab, for the rapid reversal of anticoagulant effects of dabigatran (Pradaxa).

The FDA had previously granted Breakthrough Therapy designation to idarucizumab in June 2014.

The BLA was supported by data from a number of completed and ongoing studies evaluating the safety and efficacy of idarucizumab in Pradaxa-treated patients. The researchers behind a phase 1 trial found that the use of idarucizumab led to an immediate, complete, and sustained reversal of dabigatran’s anticoagulant effects without any prothrombotic effects.

“The submissions for idarucizumab mark the first regulatory submissions for a specific reversal agent to a novel oral anticoagulant,” said Professor Jörg Kreuzer, Vice President of Boehringer Ingelheim’s Cardiovascular Medicine Therapeutic Area, in a press release. “Our discovery and development of idarucizumab in-house is an example of our company’s dedication to the evolution and innovation of anticoagulation care. Idarucizumab is being developed to provide physicians with a specifically targeted reversal agent for Pradaxa patients in rare emergency situations.”

Boehringer Ingelheim also submitted equivalent regulatory applications to European and Canadian agencies.