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FDA approves first reversal agent for anticoagulant Pradaxa

October 21, 2015

Silver Spring, Md. — The U.S. Food and Drug Administration October 16 announced its approval of Praxbind (idarucizumab), the first reversal agent for a target-specific oral anticoagulant, Pradaxa (dabigatran).

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

Praxbind is the first reversal agent approved specifically for Pradaxa. It works by binding to the drug compound to neutralize its effect, the FDA said.

This indication was approved under accelerated approval based on a reduction in unbound Pradaxa 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.

Three studies involving a total of 283 healthy volunteers taking Pradaxa to test the effect of Praxbind showed an immediate reduction in the amount of Pradaxa in participants’ blood that lasted for at least 24 hours, according to the FDA.

An interim analysis of an ongoing study that included 123 patients taking Pradaxa, who received Praxbind due to uncontrolled bleeding or because they required emergency surgery, found that the anticoagulant effect of Pradaxa was fully reversed in 89 percent of patients within four hours of receiving Praxbind, according to the FDA.

“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,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, calling the approval of Praxbind “an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.”

In healthy volunteers receiving Praxbind, headache was the most frequently reported adverse reaction in five percent or more of individuals. In patients treated with Praxbind, the most frequently reported adverse reactions in five percent or more of subjects were low potassium, delirium, constipation, fever and pneumonia.

For more information, visit FDA.gov and search for “Praxbind”.