Large-Scale Commercial Production Approved for Factor Xa Inhibition Reversal Agent – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
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.1
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.