Portola announced that the Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for its second generation Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo) for full commercial launch in the US, expanding patient access.
Andexxa was initially granted accelerated approval in May 2018 for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation was needed due to life-threatening or uncontrolled bleeding. It is the only antidote currently FDA-approved for this indication.
“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” said Scott Garland, Portola’s president and CEO.
Andexxa is available as 100mg or 200mg per vial as lyophilized powder for intravenous (IV) injection after reconstitution. According to the Company, full commercial launch is anticipated for January 2019.
For more information call (650) 246-7000 or visit Andexxa.com.