"Today's approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating. It was approved under FDA’s Accelerated Approval pathway, based on the change from baseline in anti-factor Xa activity in healthy volunteers.
Orphan Drug and FDA Breakthrough Therapy designations. The first and only reversal agent indicated for patients being treated with rivaroxaban (Xarelto, Janssen) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, has been approved by the FDA.Ĭoagulation factor Xa (recombinant), inactivated-zhzo (Andexxa, Portola received both U.S.
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