Praxbind Approved to Reverse Anticoagulant Effects of Pradaxa
October 16, 2015 – Boehringer Ingelheim received accelerated U.S. Food and Drug Administration approval for its Praxbind (idarucizumab). Praxbind is indicated to reverse the anticoagulation effects of Pradaxa (dabigatran etexilate mesylate) also manufactured by Boehringer Ingelheim. Pradaxa is used for emergency surgery or urgent procedures, and in life threatening or uncontrolled bleeding episodes. Praxbind is a humanized monoclonal antibody fragment that is administered as a single intravenous infusion while Pradaxa is an oral direct thrombin inhibitor used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa is also used for the treatment and prevention of deep venous thrombosis and pulmonary embolism.
The recommended dose of Praxbind is 5g. Note that Praxbind is the first reversal agent approved specifically for Pradaxa and its continued approval is contingent upon additional clinical data confirming its clinical benefit to be submitted by Boehringer Ingelheim.
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