Anticoagulant Reversal Agent Idarucizumab Receives Accelerated Approval
Idarucizumab (Praxbind) was recently granted accelerated approval by the FDA as a reversal agent.
Idarucizumab (Praxbind) was recently granted accelerated approval by the U.S. Food and Drug Administration as a reversal agent for the anticoagulant dabigatran in the event of emergency surgery/urgent procedures, or in life-threatening or uncontrolled bleeding.1
The approval was based on the results of 3 randomized, placebo-controlled trials that included 283 healthy volunteers who received either dabigatran and idarucizumab or dabigatran and placebo.
The primary endpoint was reduction of unbound dabigatran to undetectable levels after the administration of idarucizumab in 24 hours.
An ongoing, open-label study in 123 patients receiving dabigatran who had life-threatening or uncontrolled bleeding, or required emergency surgery/urgent procedures, also had supporting data.
The anticoagulant effect of dabigatran was completely reversed in 89% of patients, and in a limited number of patients, elevated coagulation parameters were detected.
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In regard to safety, the most common adverse event reported in 5% of healthy volunteers (n=224) was headache. From the ongoing, open-label study (n=123), the most common adverse events that occurred in 5% of participants were hypokalemia, delirium, constipation, pyrexia, and pneumonia.
Idarucizumab is used specifically for dabigatran, and it is the first anticoagulant reversal agent to receive approval.
- Idarucizumab. U.S. Food and Drug Administration website. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm467396.htm. Updated October 16, 2015. Accessed October 21, 2015.