AstraZeneca’s share price increased 0.6% in early morning trading on Tuesday following the company’s announcement that its product Ondexxya had been approved in Japan.
Japan became the first country to approve the drug for use with all three FXa inhibitors currently available.
The medicine is reportedly the first approved reversal agent for Factor X inhibitors, including apixaban, rivaroxaban and edoxaban.
Ondexxya is capable of reversing anticoagulation, which means the drug can be used to stop uncontrolled, life-threatening bleeding in patients.
The medicine is currently under conditional approval by the European Commission for adults treated with apixaban and rivaroxaban, which was received in 2019.
Ondexxya received approval from the US Food and Drug Administration (FDA) in 2018 and is marketed under the trade name Andexxa.
“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,” said AstraZeneca Executive Vice President of BioPharmaceuticals R&D Mene Pangalos.