FDA Grants Breakthrough Status to Potential Antidote for Antiocoagulant Pradaxa

The FDA has granted Breakthrough Therapy Designation to idarucizumab, a fully humanized antibody fragment being studied as an antidote for Pradaxa (dabigatran). Idarucizumab is an investigational drug, not approved for clinical use.

Lupus Research Institute Novel Research Grant awardee and Chief of the Division of Hemostasis and Thrombosis at Beth Israel Deaconess Medical Center Bruce Furie, MD explains the potential significance of idarucizumab to people with lupus:

“Many lupus patients receive anticoagulation because of prior thrombotic events.  The most typical anticoagulant used chronically is Coumadin.  The new oral anticoagulants, including Pradaxa, are effective but their anticoagulant event cannot be reversed if they start to bleed.  Some patients have bled to death.  Therefore, the company that makes Pradaxa, Boehringer Ingelheim, has developed an antibody that neutralizes Pradaxa.  This antibody is in clinical trials and has NOT been approved by the FDA.  But its clinical trial is on a fast track for evaluation.”

 

Boehringer Ingelheim reports that a Phase I study completed in 2013 showed that idarucizumab was able to achieve “instant, complete and sustained reversal of dabigatran-induced anticoagulation in healthy humans.” A phase III study is now underway, testing the drug in patients taking Pradaxa who have uncontrolled bleeding or require emergency surgery or procedures.