FDA approves AndexXa, first antidote for the reversal of factor Xa inhibitors

Following rejection by the agency in August 2016, the US Food and Drug Administration has now approved AndexXa (coagulation factor Xa [recombinant], inactivated-zhzo).

This is the first and only antidote indicated for patients treated with drug such as rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, says the drug’s developer, Portola Pharmaceuticals (Nasdaq: PTLA).

However, in 2015, the FDA granted accelerated approval to Boehringer Ingelheim’s Praxbind (idarucizumab) for use in patients who are taking the German firm’s anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.