FDA OKs BI’s PraxbindBy
Boehringer Ingelheim GmbH reports that the US Food and Drug Administration (FDA) has granted approval of Praxbind (idarucizumab) for patients treated with Pradaxa (dabigatran etexilate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
Praxbind is a humanized antibody fragment, or Fab, designed as a specific reversal agent to dabigatran. Praxbind binds specifically to dabigatran molecules only, neutralizing their anticoagulant effect without interfering with the coagulation cascade, according to the company.
Source: Boehringer Ingelheim