Portola Pharmaceuticals, the makers of an antidote for rivaroxaban (Xarelto, Bayer Pharma/Janssen Pharmaceuticals), a factor Xa inhibitor that is part of the newest generation of oral anticoagulants, announced today that a phase 3 study testing the safety and efficacy of the antidote met its primary end point.

In the trial, an 800-mg intravenous bolus of andexanet alfa, which was tested in 41 healthy volunteers treated with rivaroxaban 20 mg for 4 days and then subsequently randomized to the study drug or placebo, “immediately and significantly” reversed the steady-state anticoagulation activity of rivaroxaban.

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