FDA approves first direct reversal agent for novel oral anticoagulant


News - Oct. 19, 2015

The U.S. Food and Drug Administration (FDA) granted approval of idarucizumab. Idarucizumab is indicated for patients treated with dabigatran etexilate, when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

The FDA granted idarucizumab Breakthrough Therapy Designation and the application received Priority Review. Idarucizumab was approved under an Accelerated Approval Pathway. The application included data from healthy volunteers as well as results from an interim analysis of the RE-VERSE AD trial (NCT 02104947). In the studies, the reversal effects of idarucizumab were evident immediately, within minutes after administration of 5 grams of idarucizumab.  No procoagulant effect was observed after the administration of idarucizumab.

"The emergence of novel oral anticoagulants, or NOACs, marked a significant advancement in anticoagulation care. While general management strategies for NOAC-related bleeding are available, until today, there was no option for specific and immediate reversal of the anticoagulant effect of a NOAC in a patient in rare emergencies where speed matters, such as life threatening bleeding or the need to quickly perform surgery or interventions," said Dr. Charles Pollack, lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, USA. "The availability of idarucizumab now provides a unique option for reversing anticoagulation in patients taking idarucizumab."
 Press release Boehringer Ingelheim October 19, 2015

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