FDA Approves Reversal Agent for Anticoagulant Pradaxa

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FDA Approves Reversal Agent for Anticoagulant Pradaxa
FDA Approves Reversal Agent for Anticoagulant Pradaxa

The U.S. FDA has granted accelerated approval to Praxbind (idarucizumab) for the emergency reversal of anticoagulant Pradaxa.

Pradaxa was previously approved in 2010 for the prevention of stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of pulmonary embolism and deep venous thrombosis. Praxbind is the first reversal agent specifically for Pradaxa, and works by binding to the drug compound in order to neutralize the effect.

“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, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in an FDA 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.”

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The safety and effectiveness of Praxbind — which is delivered via intravenous injection — was evaluated in three trials in a total of 283 healthy participants who were taking Pradaxa. When given Praxbind, researchers observed an immediate reduction in unbound dabigatran plasma concentration in participants that lasted for at least 24 hours. Headache was the most common side effect observed among participants given Praxbind.

In an ongoing trial of 123 patients taking Pradaxa who received Praxbind because of uncontrolled bleeding or emergency surgery, laboratory testing indicates that the anticoagulant effect of Pradaxa was reversed in 89% of patients within four hours of receiving the Praxbind injection. Common side effects in this trial include hypokalemia, confusion, constipation, fever, and pneumonia.

Since the use of Praxbind reverses the effect of Pradaxa in patients at risk of blood clots or stroke, the drug's label recommends that patients be returned to their Pradaxa regimen as soon as medically appropriate.

Andexanet alfa, a novel reversal agent for anticoagulant Xarelto, is also currently under development by Portola Pharmaceuticals in partnership with Janssen. Prothrombin complex concentrate, or PCC, has also demonstrated efficacy as a reversal agent for Xarelto in healthy people. 

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