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Bayer AG

Finerenon (Kerendia®) erhält Update der Produktinformation in den USA zur Aufnahme der Daten aus der Phase-III-Studie FIGARO-DKD zu kardiovaskulären Ergebnissen

(PresseBox) (Berlin, )
Die US-amerikanische Food and Drug Administration (FDA) hat eine Aktualisierung der Produktinformation für Kerendia® (Finerenon) genehmigt, um die Ergebnisse der Phase-III-Studie FIGARO-DKD zu kardiovaskulären (CV) Ergebnissen bei Patienten mit chronischer Nierenerkrankung (CKD) in Verbindung mit Typ-2-Diabetes (T2D) aufzunehmen / FIGARO-DKD untersuchte zusätzlich zur Standardbehandlung die Wirksamkeit und Sicherheit von Finerenon im Vergleich zu Placebo zur Verringerung der kardiovaskulären Morbidität und Mortalität bei etwa 7.400 Patienten mit CKD in Verbindung mit T2D / FIGARO-DKD umfasste Patienten mit einem breiten Spektrum an Schweregraden der CKD in Verbindung mit T2D, einschließlich Patienten der CKD-Stadien 1-4 mit Albuminurie

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