Both Praxbind and Pradaxa are made by Boehringer Ingelheim.

According to FDA, the accelerated approval was granted based on an unmet need. So far, the lack of specific reversal agents has likely been a factor in the limited uptake of the novel oral anticoagulants (NOACs), given the potential for uncontrolled bleeding.Last month, the FDA approved idarucizumab (marketed as Praxbind) as an agent that specifically reverses the anticoagulant dabigatran (approved in 2010 as Pradaxa) to prevent stroke and systemic blood clots in patients with atrial fibrillation and to treat deep vein thrombosis and pulmonary embolism. It is specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors. Idarucizumab is indicated for patients treated with dabigatran when rapid reversal of its anticoagulant effects is required for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding, the TGA says.Īnother reversal agent for NOACs was shown to be effective in a study in the NEJM last November, but is behind idarucizumab in the approval process.Īndexanet alfa is a recombinant protein designed to reverse the anticoagulant effect in patients treated with oral or injectable Factor Xa inhibitors. The drug is not available on the PBS and will cost around $3,000 per course. The drug is given intravenously as two consecutive infusions over five to ten minutes, or as a bolus injection, according to the TGA, and is now available in Australian hospitals. It will not reverse the effect of other newer anticoagulants, such as rivaroxaban and apixaban. Idarucizumab, (Praxbind), is a monoclonal antibody that reverses the anticoagulant effect by binding specifically to dabigatran (Pradaxa). The first reversal agent for the novel oral anticoagulant dabigatran has been approved by the TGA

Idarucizumab price