“Unlike for some other anticoagulants, there is currently no approved reversal agent for Factor Xa inhibitors,” Connolly said of the therapy at the 67 th American College of Cardiology Scientific Sessions in Orlando, Florida. The FDA made its decision on andexanet based on data from the 2 phase 3 studies, ANNEXA-R and ANNEXA-A, which evaluated the antidote’s safety and efficacy in healthy volunteers, with the median decrease in anti-Factor Xa activity from baseline reported as 97% for those on rivaroxaban and 92% for those on apixaban. “Andexxa’s rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts.” Connolly, MD, the ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario, said in a statement. “Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating,” Stuart J. Previously, the Portola product had received both Orphan Drug and Breakthrough Therapy designations from the FDA, and it was granted approval under the agency’s Accelerated Approval pathway founded on the change in anti-Factor Xa activity in healthy volunteers from baseline measurements.

The US Food and Drug Administration (FDA) has approved andexanet alfa (AndexXa, Portola Pharmaceuticals) as the first and only antidote for patients treated with rivaroxaban and apixaban when the reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Apixaban antidote