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- Finerenon ist das erste den Mineralokortikoidrezeptor (MR)-Signalweg beeinflussende Medikament, das in einer Phase-III-Studie bei Patienten mit Herzinsuffizienz (HF) mit einer linksventrikulären Auswurfleistung (LVEF) von ≥40 %, d. h. mit leicht reduzierter oder erhaltener LVEF, kardiovaskuläre Vorteile gezeigt hat
- Der Zulassungsantrag basiert auf positiven Daten aus der Phase-III-Studie FINEARTS-HF, die Teil von MOONRAKER ist, einem der bislang größten klinischen Phase-III-Studienprogramme zu HF
- Die FDA erteilt den Status einer vorrangigen Prüfung für die Bewertung von Arzneimitteln, die im Falle einer Zulassung im Vergleich zu verfügbaren Therapien eine erhebliche Verbesserung der Wirksamkeit oder Sicherheit der Behandlung, Diagnose oder Vorbeugung schwerer Xbffkhrvqaqv ovrqrn kepptr
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- Finerenon ist das erste den Mineralokortikoidrezeptor (MR)-Signalweg beeinflussende Medikament, das in einer Phase-III-Studie bei Patienten mit Herzinsuffizienz (HF) mit einer linksventrikulären Auswurfleistung (LVEF) von ≥40 %, d. h. mit leicht reduzierter oder erhaltener LVEF, kardiovaskuläre Vorteile gezeigt hat
- Der Zulassungsantrag basiert auf positiven Daten aus der Phase-III-Studie FINEARTS-HF, die Teil von MOONRAKER ist, einem der bislang größten klinischen Phase-III-Studienprogramme zu HF
- Die FDA erteilt den Status einer vorrangigen Prüfung für die Bewertung von Arzneimitteln, die im Falle einer Zulassung im Vergleich zu verfügbaren Therapien eine erhebliche Verbesserung der Wirksamkeit oder Sicherheit der Behandlung, Diagnose oder Vorbeugung schwerer Xbffkhrvqaqv ovrqrn kepptr
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Veqxorftjcomiufint Ioosqzsx
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