AstraZeneca's Ondexxya receives Japanese approval

Drugmaker AstraZeneca revealed on Tuesday that its Ondexxya asset had become the first approved medicine in Japan to specifically reverse the anticoagulant effect of Factor Xa inhibitors, providing "a major advance" in the treatment of patients hospitalised with life-threatening bleeding.

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

Ondexxya received US approval from the 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.

Mene Pangalos, AstraZeneca's executive vice president of biopharmaceuticals R&D, 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."