FDA OKs first reversal agent for Pradaxa
The FDA has 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.
“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.”
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 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.
The safety and effectiveness of Praxbind were studied in three trials involving a total of 283 healthy volunteers taking Pradaxa (i.e., people who did not require an anticoagulant). In the healthy volunteers who were given Praxbind, there was an immediate reduction in the amount of Pradaxa in participants’ blood (measured as unbound dabigatran plasma concentration) that lasted for a period of at least 24 hours. In that study, the most common side effect from use of Praxbind was headache.
Another trial included 123 patients taking Pradaxa who received Praxbind due to uncontrolled bleeding or because they required emergency surgery. In the ongoing trial, based on laboratory testing, the anticoagulant effect of Pradaxa was fully reversed in 89% of patients within four hours of receiving Praxbind. In that patient trial, the most common side effects were low potassium (hypokalemia), confusion, constipation, fever and pneumonia.
Praxbind and Pradaxa are both marketed by Boehringer Ingelheim of Ridgefield, Conn.