The use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to enoxaparin and warfarin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). “Andexxa’s rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts.” Connolly, M.D., ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario.

“Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating,” said Stuart J. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients. Orphan Drug and FDA Breakthrough Therapy designations and was approved under the FDA’s Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers. Food and Drug Administration (FDA) has approved Andexxa ®, the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.Īndexxa received both U.S. ® (Nasdaq:PTLA) today announced that the U.S. SOUTH SAN FRANCISCO, Calif., (GLOBE NEWSWIRE) - Portola Pharmaceuticals, Inc. – Breakthrough Product is a Major Advance in the Treatment of Patients Hospitalized with Life-Threatening Bleeding –

Andexxa availability