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.
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