Der Kooperationspartner von Bayer HealthCare, Janssen Research & Development, LLC, hat bei der US-amerikanischen Gesundheitsbehörde Food and Drug Administration die Zulassungen des oralen Gerinnungshemmers Xarelto® (Rivaroxaban) zur Behandlung tiefer Venenthrombosen oder Lungenembolien sowie zur Sekundärprävention wiederkehrender venöser Thromboembolien (VTE) beantragt.
Die Einreichungen stützen sich auf die Ergebnisse des globalen EINSTEIN-Studien-programms mit fast 10.000 Patienten. Die drei globalen Phase-III-Studien untersuchten Wirksamkeit und Sicherheit von Rivaroxaban in der Behandlung tiefer Venenthrombosen und Lungenembolien sowie die Prävention wiederkehrender VTE. Die Ergebnisse wurden im New England Journal of Medicine (10.1056/NEJMoa1113572 sowie 10.1056/NEJMoa1007903) publiziert.
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Die Einreichungen stützen sich auf die Ergebnisse des globalen EINSTEIN-Studien-programms mit fast 10.000 Patienten. Die drei globalen Phase-III-Studien untersuchten Wirksamkeit und Sicherheit von Rivaroxaban in der Behandlung tiefer Venenthrombosen und Lungenembolien sowie die Prävention wiederkehrender VTE. Die Ergebnisse wurden im New England Journal of Medicine (10.1056/NEJMoa1113572 sowie 10.1056/NEJMoa1007903) publiziert.
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