Andexxa Approved by FDA for Large-Scale Commercial Launch

Article

Officials with the FDA approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for the Generation 2 manufacturing process for Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo].

Officials with the FDA approved Portola Pharmaceuticals’ Prior Approval Supplement (PAS) for the Generation 2 manufacturing process for Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], according to a press release.

This approval allows full commercial launch for Andexxa, which was previously launched under an Early Supply Program with Generation 1 product. The new Generation 2 manufacturing process will enable it to scale up production and stock hospitals nationwide, according to the company.

Andexxa 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.

Andexxa’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. The studies showed Andexxa rapidly 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, according to the data.

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