Tag: reversal agents

US FDA accepts Biologics License Application resubmission of reversal agent andexanet...

Portola Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has found its resubmitted Biologics License Application andexanet alfa (AndexXa) to be...
Pradaxa dabigatran etexilate manufacture

Final Phase III results support safety of idarucizumab as reversal agent...

Final results from RE-VERSE AD study show that idarucizumab, marketed in the US as Praxbind (Boehringer Ingelheim), was able to immediately reverse the anticoagulant...

Boehringer Ingelheim launches RE-VECTO global programme to explore idarucizumab use in...

Boehringer Ingelheim has announced the launch of its global RE-VECTO programme for idarucizumab (Praxbind), the specific reversal agent for dabigatran etexilate (Pradaxa). Idarucizumab is approved...

Idarucizumab licensed in Europe as specific reversal agent of dabigatran

Boehringer Ingelheim has announced that the European Commission has licensed idarucizumab (Praxbind) for rapid and specific reversal of the anticoagulant effects of dabigatran etexilate in cases of emergency surgery/urgent procedures or in situations of life-threatening or uncontrolled bleeding.