Ligand id: 8298

Name: idarucizumab

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Summary of Clinical Use
Following from FDA Breakthrough Therapy Designation, the FDA granted accelerated approval (October 2015) for idarucizumab to be used to reverse the anticoagulant effects of dabigatran in patients requiring emergency surgery or urgent procedures, or those suffering from life-threatening or uncontrolled bleeding. EMA approval for the same indications followed in November 2015.
Mechanism Of Action and Pharmacodynamic Effects
Results from a Phase I clinical trial (NCT01955720) indicate that idarucizumab rapidly and completely reverses the anticoagulant effect of dabigatran in healthy volunteers, with only mild adverse reactions (eg headache, erythema and migraine) reported [2].
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