AstraZeneca and Baxter Submit NDA for Andexanet Alfa in China

Dec 17, 2023 15:22 CST Updated 15:22

AstraZeneca

Biopharmaceutical Manufacturer

Baxter

Disease Treatment Product Developer

Source: Xinkangjie

On December 16, the official website of the Center for Drug Evaluation under the China National Medical Products Administration announced that AstraZeneca and Baxter International, Inc. had submitted a marketing application for injectable andexanet alfa, which has been accepted.

It is reported that Andexanet alfa has currently received accelerated approval in the United States and conditional approval in the European Union, Switzerland, and the United Kingdom.For patients who require reversal of anticoagulation due to life-threatening or uncontrolled bleeding after treatment with the FXa inhibitors apixaban and rivaroxaban.。

And this product is the first,It is also the only antidote for rivaroxaban and apixaban.

Previously, an article published in JAAPA discussed Andexanet alfa. The article pointed out that Andexanet alfa can bind and sequester the active sites of rivaroxaban and apixaban, reversing the anticoagulant effects associated with factor Xa inhibitors. Andexanet alfa exhibits its procoagulant effect by binding and inhibiting the activity of tissue factor pathway inhibitor.

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