CHMP grants positive opinion for idarucizumab, the specific reversal agent for Pradaxa

The Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency has issued a positive opinion following an accelerated assessment, recommending European approval of idarucizumab (to be marketed as Praxbind), German family-owned pharma major Boehringer Ingelheim announced on Friday.

Idarucizumab is intended for use in adult patients treated with Boehringer’s Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. Bleeding is a well-known complication of all anticoagulants. Pradaxa generated 1.2 billion euros ($1.3 billion) of sales in 2014.

“The CHMP positive opinion in favor of idarucizumab approval is an important recommendation in the field of anticoagulation care,” said Fausto Pinto, University of Lisbon, Portugal, and President of the European Society of Cardiology. “The introduction of non-vitamin K antagonist oral anticoagulants, or NOACs, already marked a significant advancement in anticoagulation care. The approval of specific reversal agents to stop their anticoagulant effect immediately when needed will be the next advancement,” Prof Pinto added.