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FDA approves Praxbind for Pradaxa reversal
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The FDA today granted accelerated approval to idarucizumab, which is intended for patients who require emergency reversal of dabigatran’s blood-thinning effects.
Idarucizumab (Praxbind, Boehringer Ingelheim) — administered via IV injection — is the first reversal agent approved specifically for dabigatran (Pradaxa, Boehringer Ingelheim).
Richard Pazdur
The FDA approved dabigatran in 2010 for the treatment and prevention of deep venous thrombosis and pulmonary embolism, as well as for the prevention of stroke and systemic blood clots in patients with atrial fibrillation.
“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,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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 based its approval of idarucizumab in part on results of three trials comprised of 283 healthy volunteers who were taking dabigatran. Among participants who were given idarucizumab, researchers observed an immediate reduction in the amount of dabigatran in the blood for at least 24 hours. In these participants, the most common side effect reported with idarucizumab was headache.
Another trial included 123 patients taking dabigatran who received idarucizumab due to uncontrolled bleeding, or due to the need for emergency surgery. Researchers reported the anticoagulant effect of dabigatran was fully reversed in 89% of patients within 4 hours of idarucizumab receipt. In this trial, the most frequent side effects were low potassium, confusion, constipation, fever and pneumonia.
“Boehringer Ingelheim has a strong history of leadership in researching new ways to care for patients in the cardiovascular community,” Sabine Luik, MD, senior vice president of medicine and regulatory affairs with Boehringer Ingelheim, said in a statement. “We are tremendously proud to bring a new option to physicians and patients.”