FDA Approves Praxbind® (idarucizumab), Specific Reversal Agent for Pradaxa® (dabigatran etexilate)
INGELHEIM, Germany–(BUSINESS WIRE)– Boehringer Ingelheim GmbH announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind ® (idarucizumab).4 Praxbind® is indicated for patients treated with Pradaxa ® (dabigatran etexilate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. 1
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“We are very pleased to offer Praxbind ®, the first specific reversal agent for a novel oral anticoagulant, now approved by the FDA,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa ®. While we anticipate that Praxbind ® will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added confidence in choosing Pradaxa ®.”
The FDA granted Praxbind ® Breakthrough Therapy Designation and the application received Priority Review. 5 Praxbind ® was approved under an Accelerated Approval Pathway. 6 The application included data from healthy volunteers as well as results from an interim analysis of the RE-VERSE AD™ trial (NCT 02104947). 2,3,7,8 In the studies, the reversal effects of Praxbind ® were evident immediately, within minutes after administration of 5 grams of Praxbind ®. 2,3,7,8 No procoagulant effect was observed after the administration of Praxbind ®.2,3,7
“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 Praxbind ® now provides a unique option for reversing anticoagulation in patients taking Pradaxa ®.”
Boehringer Ingelheim is committed to making Praxbind ® available as widely as possible. Praxbind ® is currently being assessed by different regulatory authorities, including Health Canada. 6 Further submissions are ongoing. 4
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
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Please click on the link below for ‘Notes to Editors’ and References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/19_october_2015_dabigatranetexilate.html
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