AstraZeneca PLC (LSE:AZN) said its Ondexxya treatment was approved in Japan, the first approved reversal agent specifically for Factor Xa inhibitors in the country.
Ondexxya is a modified form of the human FXa molecule, an enzyme that helps blood clots.
Japanese health officials approved the drug based on positive results from the company's Annexa-4 Phase III clinical trial, the company said.
For adults treated with apixaban and rivaroxaban (FXa inhibitors), Ondexxya received approval from the US Food and Drug Administration under an accelerated approval pathway in May 2018 and conditional approval from the European Commission in April 2019. Ondexxya is marketed as Andexxa in the US.
The company said Ondexxya also received approval in Japan for use along with all three FXa inhibitors: apixaban, rivaroxaban, or edoxaban.
FXa inhibitors are increasingly used to treat all types of thrombotic events, including deep vein thrombosis and pulmonary embolism.
"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," said Masahiro Yasaka of the National Hospital Organisation Kyushu Medical Centre, Fukuoka, Japan.