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Ondexxya approved in Japan for FXai reversal
Ondexxya approved in Japan for FXai reversal.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3123G\n AstraZeneca PLC\n 29 March 2022\n \n \n \n \n 29 March 2022 07:00 BST\n \n \n \n Ondexxya \n approved in Japan for reversal \n of acute major bleeds in patients on Factor Xa inhibitors\n \n \n Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with \n \n life-threatening bleeding\n \n \n \n \n \n \n Ondexxya \n (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.\n \n \n \n \n \n The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the\n \n \n ANNEXA-4 Phase III clinical \n trial\n \n showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding.\n \n \n \n \n \n Ondexxya \n 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.1,2\n \n \n \n \n \n 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 un...