First Reversal Agent for Pradaxa Now FDA-Approved

The Food and Drug Administration (FDA) has grated accelerated approval to Praxbind (idarucizumab; Boehringer Ingelheim) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa's blood-thinning effects.

The approval is based on results from three clinical trials of 283 healthy volunteers taking Pradaxa who were given Praxbind. An immediate reduction in the amount of Pradaxa in the participants' blood was observed, and this effect lasted for at least 24 hours. Another trial of 123 patients taking Pradaxa and receiving Praxbind due to uncontrolled bleeding or emergency surgery found that the anticoagulation effect of Pradaxa was fully reversible in 89% of patients within four hours of receiving Praxbind.

Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize its effect; it is for intravenous injection. It is advised that patients resume their anticoagulation therapy as soon as medically appropriate, after receiving Praxbind, as determine by their healthcare provider.

RELATED: Rapid Reversal Seen With Idarucizumab in Pradaxa-Treated Patients

The FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis and pulmonary embolism.

“The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug's effects is medically necessary,” stated Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. “Today's approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can't be controlled.”

For more information call (888) 463-6332 or visit FDA.gov.

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