Japan: drug approved for treatment of life-threatening bleeding

pharmafile | March 29, 2022 | News story | Manufacturing and Production  

AstraZeneca has announced that Ondexxya has become the first approved medicine in Japan to reverse the anticoagulant effect of Factor Xa inhibitors apixaban, rivaroxaban or edoxaban, when needed due to life-threatening bleeding.

The drug to reverse the anticoagulation of these treatments provides a “major advance” to patients with uncontrolled bleeding.

FXa inhibitors are increasingly used in the prevention and treatment of thrombotic events – that is, when blood clots block veins or arteries – including deep vein thrombosis, and pulmonary embolism, or in patients at high risk of a stroke due to an irrefular heart rate (atrial fibrillation).

While these inhibitors prevent unwanted blood clots, they can also increase the risk of major bleeding, which can be life-threatening.

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.”

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

The approval marks Japan as the first country to provide full regulatory approval of Ondexxya for use with all three of the FXa inhibitors currently available.

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.”

Ana Ovey

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