Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.
"We are very pleased to offer PRAXBIND, the first specific reversal agent for a novel oral anticoagulant, now approved by the FDA," said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "With this approval, Boehringer Ingelheim is again leading the evolution of anticoagulation care, as we did with the introduction of PRADAXA. 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 assurance in choosing PRADAXA."
The FDA granted PRAXBIND Breakthrough Therapy Designation and the application received Priority Review. PRAXBIND was approved under an Accelerated Approval Pathway. The application included data from healthy volunteers as well as results from an interim analysis of the RE-VERSE AD™ trial (NCT02104947). In the studies, the reversal effects of PRAXBIND were evident immediately, within minutes after administration of 5 grams of PRAXBIND. No procoagulant effect was observed after the administration of PRAXBIND.
There are serious risks to consider when treating patients with PRAXBIND, including warnings and precautions for thromboembolic risk, re-elevation of coagulation parameters, hypersensitivity reactions and risks of serious adverse reactions in patients with hereditary fructose intolerance due to sorbitol excipient. The most frequently reported adverse reactions (≥5%) in PRAXBIND-treated healthy volunteers was headache and in the Phase III RE-VERSE AD study were hypokalemia, delirium, constipation, pyrexia and pneumonia.
"The emergence of novel oral anticoagulants, or NOACs, marked a significant advancement in anticoagulation care. 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. Charles Pollack, lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia. "The availability of PRAXBIND now provides a unique option for reversing anticoagulation in patients taking PRADAXA."
PRAXBIND will be available from major U.S. hospital pharmacy distributors. Boehringer Ingelheim is committed to making PRAXBIND available as quickly as possible.
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