Anticoagulation reversal agent Ondexxya approved in Japan

Ondexxya (recommend andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Ondexxya is the first approved medicine in Japan to specifically reverse the anticoagulant effect of FXa inhibitors in patients experiencing acute major bleeding. Japan is the first country to provide full regulatory approval of Ondexxya for use with all three of the FXa inhibitors currently available.

Rights to the drug were acquired from originator Portola Pharmaceuticals by Alexion, the US rare disease drug that was subsequently acquired by UK pharm major AstraZeneca (LSE: AZN), which says that Ondexxya represents one of the newest opportunities to further advance the therapy area’s bold ambition to stop, reverse and cure CVRM diseases and transform patient care.