2Īdditionally, data from 185 patients showed that Andexxa rapidly and significantly reversed anti-Factor Xa activity when administered as a bolus and sustained reversal when followed by a 120-minute infusion, with a median decrease from baseline of 90% for rivaroxaban and 93% for apixaban. The median decrease in anti-Factor Xa activity from baseline was 97% for rivaroxaban and 92% for apixaban, according to the data. The studies showed Andexxa rapidly and significantly reversed anti-Factor Xa activity. The new Generation 2 manufacturing process will enable it to scale up production and stock hospitals nationwide, according to the company.Īndexxa originally received regulatory approval in May 2018 under the FDA’s Accelerated Approval pathway as the first antidote indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.Īndexxa’s approval was based on data from two 2 phase 3 studies which evaluated the safety and efficacy in reversing anticoagulant activity of rivaroxaban and apixaban in health volunteers. This approval allows full commercial launch for Andexxa, which was previously launched under an Early Supply Program with Generation 1 product. Officials with the FDA approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for the Generation 2 manufacturing process for Andexxa, according to a press release.

Andexxa trial