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AstraZeneca PLC on Tuesday said its reversal agent Ondexxya has been fully approved in Japan for reversal of acute major bleeds in some patients.
People on factor Xa inhibitors with major bleeds are eligible for treatment. Xa inhibitors are anticoagulants used to prevent blood clots, deep vein thromboses and strokes in people with atrial fibrillation, an abnormal heart rhythm.
However, the anticoagulant effect can cause life-threatening or uncontrolled bleed. AstraZeneca's Ondexxya, a designed protein, is used to reduce the amount of bleeding. ‘Ondexxya is a modified form of the human FXa molecule, an enzyme that helps blood clot,’ the firm added.
Japan is the first country to provide full regulatory approval of Ondexxya for use with all three of the FXa inhibitors currently available, the Cambridge, England-based pharmaceutical company explained.
In the past, the agent received approval by the US Food & Drug Administration under the accelerated approval pathway in May 2018 and conditional approval by the European Commission in April 2019 for adults treated with two types of FXa inhibitors.
In the US, Ondexxya 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 Mene Pangalos, executive vice president of AstraZeneca's BioPharmaceuticals research & development arm.
AstraZeneca shares were 0.6% higher at 9,957.00 pence each in London on Tuesday morning.
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