Regulatory Decision Summary for PRAXBIND

Pradaxa (dabigatran) is a blood thinner drug which is associated with the potential risk of severe and life-threatening bleeding. There was no specific antidote in Canada for dabigatran.

The efficacy and safety of Praxbind were evaluated in 3 clinical trials in healthy volunteers and on going single arm case series study in patients. In healthy volunteers, administration of 5 g idarucizumab resulted in an immediate reduction of unbound dabigatran in plasm and a rapid, complete and durable reversal of the anticoagulant effect of the dabigatran. The interim analysis of the ongoing study in dabigatran-treated patients with life-threatening/uncontrolled bleeding or requiring emergency surgery/procedures also showed a complete reversal in more than 89% of the patients treated with 5 g idarucizumab.

Praxbind is in general safe in healthy volunteers. Stopping treatment with the blood thinning drug Pradaxa in patients, may lead to increased risk of a blood clot in major blood vessels in lungs or heart. Mild symptoms of potential hypersensitivity were reported in clinical studies. There were no safety concerns that would preclude the authorization of Praxbind under the NOC/c policy.

Based on the demonstrated reversal of anticoagulation effect induced by dabigatran in healthy volunteers and the promising results in patients with an acceptable safety profile, the overall risk benefit profile of Praxbind is favorable for the proposed indications, in accordance with the NOC/c policy. To meet the conditions, Boehringer Ingelheim has committed to submit the final clinical trial results to verify the reversal effect of Praxbind and the clinical benefit in patients.

For more information on Health Canadas decision, please view the Summary Basis of Decision.