FDA Says Yes To Praxbind — The First Reversal Agent For The Anticoagulant Pradaxa

Photo Credit: The U.S. Food and Drug Administration - FDA Building 31.
Photo Credit: The U.S. Food and Drug Administration – FDA Building 31.

The U.S. Food and Drug Administration has granted accelerated approval to Praxbind (idarucizumab), a drug marketed by Boehringer Ingelheim of Ridgefield, Connecticut.

Praxbind is used by patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

“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.

“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,” he continued.

In 2010, the FDA gave the nod to Pradaxa, a drug marketed by the same company.

Pradaxa is used to prevent stroke and systemic blood clots in patients with atrial fibrillation as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.

Praxbind is the first reversal agent approved specifically for Pradaxa and works by binding to the drug compound to neutralize its effect. Praxbind solution is for intravenous injection.

Davy Desmond, Readers Bureau, Fellow

Editing by Jesus Chan

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