Portola's Andexxa garners FDA approval as antidote for reversal of Factor Xa inhibitors

Portola Pharmaceuticals announced that the FDA approved Andexxa (andexanet alfa) as the first antidote indicated for patients treated with Bayer and Johnson & Johnson's Xarelto (rivaroxaban) and Bristol-Myers Squibb and Pfizer's Eliquis (apixaban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The company indicated that it initially plans to launch Andexxa in June, with a broader commercial roll-out in early 2019 upon clearance of its second-generation manufacturing process.

According to Portola, the approval comes under the FDA's accelerated scheme, and was based on the change from baseline in anti-Factor Xa activity in healthy volunteers, with post-marketing requirements consisting of a clinical study comparing Andexxa to usual care, with results expected in 2023. Late last year, the agency extended its review of Andexxa by three months to May 4 after Portola submitted additional data on the drug requested by the regulator.

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The approval is supported by data from the Phase III ANNEXA-R and ANNEXA-A studies, which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors Xarelto and Eliquis in healthy volunteers. Results demonstrated that Andexxa rapidly and significantly reversed anti-Factor Xa activity, with a median decrease in anti-Factor Xa activity from baseline of 97 percent for Xarelto and 92 percent for Eliquis.

The company added that interim data from the ongoing ANNEXA-4 trial, which includes patients with major bleeding, were also reviewed by the FDA. Data from 185 evaluable patients showed that Andexxa "rapidly and significantly" reversed anti-Factor Xa activity when administered as a bolus and sustained this reversal when followed by a 120-minute infusion. Portola added that the median decrease from baseline was 90 percent for Xarelto and 93 percent for Eliquis.

A marketing application for Andexxa is also under review in Europe, with the European Medicines Agency's Committee for Medicinal Products for Human Use issuing a positive trend vote in February, with a formal decision from the European Commission expected in early 2019.

For related analysis, see ViewPoints: Portola faces three-year delay for AndexXa launch- or maybe not?

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