EC OKs BI’s Antibody Fragment PraxbindBy
The European Commission (EC) has approved Boehringer Ingelheim’s (BI) Praxbind (idarucizumab), a treatment to rapidly and specifically reverse the anticoagulant effects of BI’s Pradaxa (dabigatran etexilate) in cases of emergency surgery /urgent procedures or in situations of life-threatening or uncontrolled bleeding. Idarucizumab is the first specific reversal agent for a non-vitamin K antagonist oral anticoagulant to be approved in the European Union, according to BI.
The approval of idarucizumab by the EC follows the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2015. Idarucizumab was approved by the US Food and Drug Administration in October 2015.
Idarucizumab is a humanized antibody fragment, or Fab, designed as a specific reversal agent to dabigatran. Idarucizumab binds specifically to dabigatran molecules only, neutralizing their anticoagulant effect without interfering with the coagulation cascade. Regulatory reviews and submissions in other countries are ongoing. BI plans to submit idarucizumab in all countries where dabigatran is licensed.
Source: Boehringer Ingelheim