The European Commission has approved Portola's Andexxya for anticoagulant in the event of life-threatening or uncontrolled bleeding
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, Portola(http:// announcedthat the European Commission (EC) had the conditions to approve Andexxya (andexanet alfa) for anticoagulant reversal spawning in the event of life-threatening or uncontrolled bleedingPortola has plans to launch Andexxya in selected European countries in the second half of 2019In the U.S., Andexxya, whose brand name Andexxa, was approved by theFDA(http://in May 2018, becoming the first and only detoxificationdrug in the U.Smarket with a coagulation factor,(http://related studies
the European Commission's conditional approval of Andexxya is based on data from two Phase III ANNEXA studies (ANNEXA-R, ANNEXA-A) and the IIIb/IV phase ANNEXA-4 studyThe first two studies assessed the safety and efficacy and effectiveness of Andexxya in the anticoagulant activity of the reversing factor Xa inhibitor Sofaban or apixaban in subjectsHealth(http:// and the efficacy and safety of Andexxya in 352 patients with bleeding data from all three studies were published in the New England Journal of Medicine (NEJM) research data confirm the safety and effectiveness of andexxya reversal factor Xa inhibitors, devachaban and apixaban anticoagulant The results showed that Andexxa was able to quickly and significantly reverse the activity of anti-Xa factor, with a 97% decrease in the activity of devachaban and a 92% decrease in apixaban activity compared to the baseline
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