In a comeback, Portola scores FDA accelerated approval for once-rejected Andexxa
The anti-anticoagulant — to be marketed as Andexxa — won the OK via the accelerated approval pathway, meaning that Portola will have to run a post-marketing trial to demonstrate an ability to control bleeding in patients. The approval was based on data from two Phase III studies, conducted among healthy volunteers, that showed Andexxa could reverse anticoagulant activity of the Factor Xa inhibitors Xarelto (rivaroxaban) and Eliquis (apixaban). The drug also comes with a black box warning and is indicated for use when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
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