Portola announced that the Food and Drug Administration (FDA) has approved Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo), the first antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Andexxa, a recombinant modified human Factor Xa (FXa) protein, was approved under the FDA’s Accelerated Approval pathway. Continued approval is contingent upon post-marketing study data to demonstrate an improvement in hemostasis in patients.
Andexxa exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. It has not been shown to be effective for the treatment of bleeding related to any other FXa inhibitor.
The approval of Andexxa was based on two Phase 3 studies (ANNEXA-R and ANNEXA-A), which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of rivaroxaban and apixaban in healthy participants. The data showed Andexxa quickly and significantly reversed anti-Factor Xa activity. The median decrease in anti-Factor Xa activity from baseline was 97% for rivaroxaban and 92% for apixaban.
In addition, the FDA also reviewed interim data from ANNEXA-4, a single-arm, open-label study in patients with major bleeding. Among the evaluable patients (N=185), Andexxa quickly and significantly reversed anti-Factor Xa activity when given as a bolus; the effect was sustained when followed by a 120-minute infusion. The median decrease from baseline was 90% for rivaroxaban and 93% for apixaban.
Andexxa will be available under an Early Supply Program with Generation 1 product in early June; a bigger commercial launch is anticipated for 2019 pending FDA approval of its Generation 2 manufacturing process.
Andexxa is supplied as a lyophilized powder in single-use vials of 100mg of coagulation factor Xa (recombinant), inactivated-zhzo.
For more information call (866) 777-5947 or visit Andexxa.com.