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 a press release. “Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating,” said Stuart J. The median decrease in anti-Factor Xa activity from baseline was 97% for rivaroxaban and 92% for apixaban. As described in the label, results revealed that andexXa alfa quickly and meaningfully reversed anti-Factor Xa activity. The approval is reinforced by data from a pair of Phase 3 ANNEXA studies - ANNEXA-R and ANNEXA-A – published in The New England Journal of Medicine, which assessed the safety and efficacy of the therapy in overturning the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers. Orphan Drug and FDA Breakthrough Therapy designations, and was approved under the FDA’s Accelerated Approval pathway based on changes from baseline in anti-Factor Xa activity in healthy volunteers.Ĭontinued approval for this indication may be contingent upon post-marketing study results to exhibit an improvement in hemostasis in patients. With the news, Portola Pharmaceuticals’ drug becomes the first and only antidote approved for the indication. Food and Drug Administration (FDA) has approved coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa) for patients treated with rivaoxaban and apixaban, when reversal of anticoagulation is necessary due to fatal or uncontrolled bleeding.
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