FDA gives accelerated approval to Praxbind

The U.S. Food and Drug Administration gave accelerated approval to Praxbind (idarucizumab) on Oct. 16. 

Praxbind is intended 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.

Praxbind and Pradaxa are marketed by Boehringer Ingelheim of Ridgefield, Connecticut.

“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,” FDA Center for Drug Evaluation and Research Office of Hematology and Oncology Products Director Richard Pazdur said. “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.”

In 2010, the FDA approved Pradaxa 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. Praxbind is the first reversal agent approved specifically for Pradaxa.

The safety and effectiveness of Praxbind were studied in three trials. In the healthy volunteers who were given Praxbind, there was an immediate reduction in the amount of Pradaxa in participants’ blood lasted for a period of at least 24 hours. In this study, the most common side effect from use of Praxbind was headache.
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