Die US-amerikanische Zulassungsbehörde FDA (Food and Drug Administration) hat den Antrag zur Prüfung von Finerenon zur Behandlung von Patienten mit chronischer Nierenerkrankung (CKD) und Typ-2-Diabetes (T2D) angenommen und den Status der vorrangigen Prüfung („Priority Review“) gewährt. Der Zulassungsantrag basiert auf den Daten der Phase-III-Studie FIDELIO-DKD, deren Ergebnisse bei der „Kidney Week Reimagined 2020“, dem Kongress der American Society of Nephrology (ASN) präsentiert und gleichzeitig im New England Journal of Medicine im Oktober 2020 veröffentlicht wurden.
Mit einem sogenannten „Priority Review“ sagt die FDA eine Zulassungsentscheidung binnen sechs statt der üblichen zehn Monate zu.
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Mit einem sogenannten „Priority Review“ sagt die FDA eine Zulassungsentscheidung binnen sechs statt der üblichen zehn Monate zu.
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