to prevent thrombosis after
knee replacement surgery
© Boehringer Ingelheim
Health Canada has granted conditional approval for idarucizumab (Praxbind), a humanized antibody fragment designed to reverse the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.
The conditional approval of idarucizumab reflects the promising nature of the available clinical evidence.
For the drug to gain full approval, Boehringer Ingelheim—the company that markets both idarucizumab and dabigatran—must provide Health Canada with data confirming that idarucizumab provides a clinical benefit.
To date, study results have demonstrated that 5g of idarucizumab provides immediate, complete, and sustained reversal of the anticoagulant effects of dabigatran in most patients.
In the ongoing phase 3 RE-VERSE AD trial, researchers are evaluating idarucizumab in emergency settings.
Interim results from this trial showed that idarucizumab normalized diluted thrombin time and ecarin clotting time in a majority of dabigatran-treated patients with uncontrolled or life-threatening bleeding complications and most patients who required emergency surgery or an invasive procedure.
Researchers said there were no safety concerns related to idarucizumab. However, 23% of patients in this trial experienced serious adverse events, 20% of patients died, and several patients had thrombotic or bleeding events.
