![]() ![]() In group A, 68% of evaluable patients (134/203) had confirmed bleeding cessation within 24 hours of idarucizumab administration. The median maximum percentage reversal was 100%, as assessed on the basis of either the diluted thrombin time or the ecarin clotting time. The study’s primary endpoint was the degree of reversal of the anticoagulant effect of dabigatran achieved by idarucizumab within 4 hours. Group B included 202 patients requiring an invasive procedure or an emergency surgery or intervention (eg, surgery for an open fracture after a fall).Group A included 301 patients with uncontrolled or life-threatening bleeding complications (eg, intracranial hemorrhage or severe trauma after a car accident).The trial enrolled 503 patients who required dabigatran reversal. When the FDA granted idarucizumab accelerated approval, continued approval of the drug was contingent upon results from the phase 3 RE-VERSE AD™ trial.įinal results from RE-VERSE AD were published in NEJM in July 2017. ![]() 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. The US Food and Drug Administration (FDA) has granted full approval to idarucizumab (Praxbind ®), the specific reversal agent for dabigatran etexilate mesylate (Pradaxa ®). ![]()
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