Dabigatran Antidote Praxbind Picks Up Full FDA Approval

Patrice Wendling


April 18, 2018

The US Food and Drug Administration (FDA) has given full approval to idarucizumab (Praxbind) to reverse the anticoagulant effect of dabigatran (Pradaxa) in the event of urgent surgery or life-threatening or uncontrolled bleeding, Boehringer Ingelheim has announced.

The FDA granted accelerated approval to the monoclonal antibody fragment in October 2015, with continued approval contingent upon the results of the recently completed RE-VERSE AD trial.

As reported last fall by theheart.org | Medscape Cardiology, results of the nearly 500-patient phase 3 trial were "overwhelmingly convincing," showing that two bolus doses of idarucizumab achieved full reversal of dabigatran, an oral direct thrombin inhibitor, within about 10 minutes in almost every case. No adverse safety signals were observed and there was a low rate of thrombotic events.

In clinical trials, idarucizumab has not shown a procoagulant effect, according to the company news release posted April 17. The most frequently reported adverse events in at least 5% of patients were constipation (7%) and nausea (5%).

A decision on FDA approval for the investigational factor Xa reversal agent, andexanet alfa (AndexXa, Portola Pharmaceuticals) is expected soon, after reporting positive results last month in the ANNEXA-4 trial.

Factor Xa inhibitors include apixaban (Eliquis, Bristol-Myers Squibb), edoxaban (Savaysa/Lixiana, Daiichi Sankyo), and rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals).

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