FDA accelerated approval for Praxbind, first reversal agent for Pradaxa

The US Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) 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 was developed by German family-owned pharma major Boehringer Ingelheim, which is also the originator and marketer of Pradaxa, which generated 1.2 billion euros ($1.37 billion) of sales in 2014.

“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, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, adding: “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.”