Now, the drug has full approval for use in reversing dabigatran’s anticoagulant effects in patients who require emergency surgery/urgent procedures and those who experience life-threatening or uncontrolled bleeding. Idarucizumab received accelerated approval from the FDA in October 2015. Praxbind is currently being assessed by different regulatory authorities, including Health Canada.6 Further submissions are ongoing.The US Food and Drug Administration (FDA) has granted full approval to idarucizumab (Praxbind ®), the specific reversal agent for dabigatran etexilate mesylate (Pradaxa ®). “The availability of Praxbind now provides a unique option for reversing anticoagulation in patients taking Pradaxa.”īoehringer Ingelheim is committed to making Praxbind available as widely as possible. Charles Pollack, lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, USA.
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.
“The emergence of novel oral anticoagulants, or NOACs, marked a significant advancement in anticoagulation care. No procoagulant effect was observed after the administration of Praxbind, according to Boehringer Ingelheim. In the studies, the reversal effects of Praxbind were evident immediately, within minutes after administration of 5 grams of Praxbind. 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). The FDA granted Praxbind Breakthrough Therapy Designation and the application received Priority Review. 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.” “With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa. “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.
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