AstraZeneca's Ondexxya gets approval in Japan to reverse effect of anti blood clot drugs
The Japanese Ministry of Health, Labour and Welfare approved AstraZeneca's (NASDAQ:AZN) Ondexxya 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.
FXa inhibitors are used to prevent and treat blood clot in veins or arteries, or in patients at high risk of a stroke due to an irregular heart rate. While they prevent unwanted clots from forming, they can also increase the risk of major bleeding, which can be life-threatening.
The British drugmaker said the approval was based on positive results from a phase 3 trial, dubbed ANNEXA-4, showing Ondexxya (andexanet alfa) rapidly reversed anti-FXa activity in patients with acute major bleeding.
The company added that Ondexxya is the first approved drug 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.
In the U.S. Ondexxya was approved under the accelerated approval pathway and is marketed as Andexxa, and in the EU the drug has conditional approval for adults treated with FXa inhibitors apixaban and rivaroxaban.