Ondexxya (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.

The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ANNEXA-4 Phase III clinical trial showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding.

Ondexxya is the first approved medicine in Japan to specifically reverse the anticoagulant effect of FXa inhibitors apixaban, rivaroxaban or edoxaban in patients experiencing a life-threatening or uncontrolled bleed. Japan is also the first country to provide full regulatory approval of Ondexxya for use with all three of the FXa inhibitors currently available. FXa inhibitors are increasingly used for the prevention and treatment of thrombotic events, including deep vein thrombosis and pulmonary embolism, or in patients at high risk of a stroke due to an irregular heart rate (atrial fibrillation). While they prevent unwanted clots from forming, they can also increase the risk of major bleeding, which can be life-threatening.

Masahiro Yasaka, MD, PhD, National Hospital Organisation Kyushu Medical Centre, Fukuoka, Japan, said: “FXa inhibitors are essential medicines for people prone to developing blood clots, but they can also present a risk of uncontrolled bleeding and related complications, which can be fatal if left untreated. Ondexxya’s rapid reversal of the anticoagulating effects of apixaban, rivaroxaban and edoxaban effectively reduces the bleeding and is a major advancement in patient care.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “With the approval of Ondexxya in Japan, we are working to make this important medicine available as quickly as possible for the small proportion of patients with life-threatening or uncontrolled bleeding who are on FXa inhibitors and who have not previously had an approved reversal agent treatment option.”

Ondexxya received approval by the US Food and Drug Administration under the accelerated approval pathway in May 2018 and conditional approval by the European Commission in April 2019 for adults treated with FXa inhibitors apixaban and rivaroxaban. In the US, Ondexxya is marketed under the trade name Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo].