The US Food and Drug Administration (FDA) has approved a prior approval application that should allow for "broad commercial launch in the United States" of the factor Xa reversal agent andexanet alfa (Andexxa, Portola Pharmaceuticals), the company announced today.
Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo) was approved in May 2018 under the FDA's accelerated approval pathway and is the only agent to specifically reverse the anticoagulation effects of rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals) and apixaban (Eliquis, Bristol-Myers Squibb).
Access to the drug, however, was limited to about 40 hospitals, pending approval of Portola's generation 2 manufacturing process.
"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," Portola President and Chief Executive Officer Scott Garland said in the news release.
"We are pleased to now be able to stock hospitals nationwide and serve all patients in the US who could benefit from the potential lifesaving impact of Andexxa," he said.
Additional details on Andexxa's commercial launch will be provided during Portola's annual corporate webcast, scheduled for 7:00 AM PT January 8. The live webcast will be available at www.portola.com.
Cite this: FDA Approves Commercial Production for Bleeding Antidote Andexxa - Medscape - Jan 02, 2019.