The patients were administered with 5mg of apixaban twice daily for 3.5 days. The FDA’s approval of Andexxa ® is supported by data from two Phase III studies named ANNEXA-A and ANNEXA-R, which revealed the successful reversal of anticoagulant activity for factor Xa inhibitor anticoagulants Xarelto (rivaroxaban) and Eliquis (apixaban).Īlso known as the apixaban reversal study, ANNEXA-A enrolled patients with a median age of 57 years. The drug is available as a 100mg lyophilised powder in a single-use vial for intravenous injection. The Andexxa protein also has the ability to bind and inhibit the activity of tissue factor pathway inhibitor (TFPI), which increases tissue factor-initiated generation of thrombin. The andexanet alfa contained in Andexxa ® is a modified recombinant protein that blocks factor Xa inhibitors rivaroxaban and apixaban, and reverses their anticoagulant effect. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is expected to give a formal opinion on Andexxa ® by the end of 2018 and the European Commission (EC) is expected to issue its decision in early-2019.
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